Treatment Principles​

Presentation

Treatment Principles​

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Treatment Principles​
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Treatment should be optimized for each individual in order to improve the outcome​
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Key message: Treatment outcomes can be optimized for an individual by skillful utilization and coordination of pharmacological, psychosocial, and educational resources ​

Background​
A clinically effective treatment is characterized by:​

  • Long-term reduction in symptoms of disease, treatment burden (side effects), and impact of the disease on the patient and members of his or her social circle​
  • Sustained adherence by the patient to the prescribed treatment regimen​
  • Long-term increase in healthy behaviors and restoration of wellness​

Skillful utilization and coordination of available pharmacological, psychosocial, and educational resources targeted to each patient’s personal situation, goals, and current phase of illness can ultimately maximize clinical effectiveness across all four of the outcome domains (symptoms of disease, treatment burden, disease burden, and overall health and wellness)​

A recovery orientation, along with a culture of setting specific treatment goals, selecting treatments with a larger evidence base, and monitoring the individual patient’s response to treatment in a reliable and explicit manner serve to minimize disease burden (while adding minimal treatment burden) in order to maximize the health and wellness of the individual patient​​

  1. Tandon R et al. J Psychiatr Pract. 2006;12(6):348–363.​
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Psychosocial interventions should be tailored to the goals, needs, abilities and circumstances of individuals​
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Key message: Psychosocial interventions should be tailored to the carefully assessed goals, needs, abilities, and circumstances of individuals rather than assuming a ‘one size fits all’ approach.​

Background​
Psychosocial interventions work synergistically with medication to optimize treatment adherence and successful community living​

Optimal management requires the integration of medical and psychosocial interventions. Such interventions should not be seen as competing approaches but, in most cases, as necessary complementary interventions to improve clinical symptoms, functional outcome and quality of life​

Effective psychosocial interventions may improve medication adherence, reduce risk of relapse and the need for readmission to hospital, reduce distress resulting from symptoms, improve functioning and quality of life, and provide support for patients, their families and caregivers​

Common comorbid conditions such as substance abuse, anxiety disorders, and depression need to be recognized and addressed with psychosocial interventions​

  1. Canadian Psychiatric Association. Can J Psychiatry. 2005;50(13 Suppl 1):7S–57S.​
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Continuous maintenance treatment may decrease deterioration in symptoms during the second year following diagnosis​
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Key message: Continuous maintenance treatment is more effective than targeted intermittent treatment in preventing relapse​

Background​
This randomized controlled trial investigated the impact of continuous maintenance treatment vs targeted intermittent treatment in the second year following the diagnosis of schizophrenia​

A total of 96 first-episode patients were enrolled from the German Research Network on Schizophrenia, and 44 were assigned to treatment​

Participants assigned to the maintenance treatment arm in the second year of the trial demonstrated decreased risk of relapse and a higher survival rate from deterioration​

Clinical deterioration: Increase from baseline in the sum of PANSS positive and negative scores ≥25% or ≥10 points (if baseline value ≤40) or a CGI-C score ≥6.​

Mean survival time (Kaplan–Meier estimates): intermittent treatment = 41.0 weeks; maintenance treatment = 50.0 weeks; log rank = 13.4; p>0.001​

  1. Gaebel W, et al. J Clin Psychiatry. 2011;72(2):205–218. ​
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Only a small proportion of patients with schizophrenia achieve recovery​
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Key message: Some patients with schizophrenia may achieve recovery  with effective treatment. Social functioning, medication adherence, and type of antipsychotic are important predictors of recovery​

Background
In a 3-year observational study of adults with schizophrenia (n=6642), the frequency and predictors of patient outcomes were assessed1​

The average age at entry was 40.2 years (standard deviation=12.9 years), and mean duration of illness was 11.8 years ​

Long-lasting symptomatic remission was defined as achieving a level of severity that was mild or less (i.e., a score of <4 on a scale from 1 to 7) in the CGI-SCH positive, negative, cognitive, and overall severity scores, plus no inpatient admission for a minimum period of 24 months maintained until the 36-month visit​

  • 33% achieved long-lasting symptomatic remission​

Long-lasting adequate quality of life was defined as achieving an EQ-5D VAS score ≥70 for a minimum period of 24 months and maintaining it until the 36-month visit​

  • 27% achieved long-lasting adequate quality of life​

Long-lasting functional remission was defined as fulfilling the following 3 criteria for a minimum period of 24 months and maintaining  them until the 36-month visit: (1) a positive occupational/vocational status (i.e., paid or unpaid full- or part-time employment, being an active student, or being a housewife); (2) living independently; and (3) having active social interactions (i.e., having more than 1 social contact during the past 4 weeks or having a spouse or partner)​

  • 13% achieved long-lasting functional remission​

Although the results should be interpreted conservatively because of the observational, non-randomized study design, they indicate that only a small proportion of patients with schizophrenia achieve recovery, and suggest that social functioning, medication adherence, and type of antipsychotic are important predictors of recovery​

  1. Novick D, et al. Schizophr Res. 2009;108(1–3):223–230.
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How do medication side effects exacerbate functional impairment?​
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Take home points​
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Side effects of treatments for schizophrenia can impose a significant burden on patients​
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​Key message: Treatment side effects, which are reported by the majority of patients with schizophrenia, can impose a significant burden on patients, reducing quality of life and causing long-term distress if not treated.​

Background1​
In an Australian study that combined the findings of two studies of patients with psychosis (the first in 1997–98 [n=687], the second in 2010 [n=1211]), 77.4% reported medication side effects in the previous 4 weeks, 61.0% reported impairment due to medication side effects, and 29.9% reported moderate/severe impairment due to side effects​

Both the 1997−98 and 2010 surveys had similar aims, employed the same two-phase design and methodology and used the same core instruments: the ‘Psychosis Screener’ for census month screening and the ‘Diagnostic Interview for Psychosis’ for the interview​

The proportions reporting medication side effects and associated impairment were comparable for both survey periods​

Both the 1997−98 and 2010 surveys had similar aims, employed the same two-phase design and methodology and used the same core instruments: the Psychosis Screener for census month screening and the Diagnostic Interview for Psychosis for the interview, although the 2010 interview schedule was an enhanced version of the 1997−98 schedule with many additional questions and assessments​

Questions from the 1997−98 psychosis survey were included to enable an assessment of change over time​

  1. Morgan VA, et al. Aust N Z J Psychiatry. 2012;46(8):73552. ​
  2. Awad AG, et al. Acta Psychiatr Scand Suppl. 1994;380:27–32.​
  3. Barnes TR, et al. J Psychopharmacol. 2011;25(5):567–6203. ​
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Side effects can be classified into different groups​
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Key message: There are many different side effects that can be induced by antipsychotics, and these can be classified into different groups such as sedating, activating, metabolic etc. ​

 

  1. Jibson MD. Second-generation antipsychotic medications: pharmacology, administration, and comparative side effects. In: UpToDate, Stephen Marder (Ed), UpToDate: Waltham, MA. Accessed March 13, 2015. ​
  2. Lehman AF, et al. [APA Practice Guidelines] 2010. ​
  3. Lieberman JA, et al. N Engl J Med. 2005;353(12):1209–23. ​
  4. Kane JM, et al. Schizophr Res. 2016 pii: S0920-9964(16)30162–1.​
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There are multiple clinical benefits of a low risk of extrapyramidal symptoms​
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Key message: Akathisia is associated with emotional symptoms (e.g. reduced self-esteem, anxiety, depression and paranoid ideation) and cognitive impairment (e.g. problems with mental control, associate learning, perception and coping) ​

Background1​
In a cross-sectional study 80 patients with a schizophrenic disorder (according to ICD-10 criteria) who had an illness duration of over 1 year were investigated, using various rating scales: Positive and Negative Syndrome Scale (PANSS), the St. Hans Rating Scale for EPS, the UKU Side Effect Rating Scale, the Drug Attitude Inventory, and the Lancashire Quality of Life Profile​

Mild to moderate akathisia was reported in 23% of all patients, and there was a significant correlation between akathisia (St. Hans scale) and self-esteem (-0.32**, **p<0.01)​

Background2​
67 outpatients with schizophrenia receiving stable doses of risperidone or haloperidol were evaluated for akathisia and other extrapyramidal side effects​

Subjective cognitive dysfunction was comprehensively assessed using the Frankfurt Complaint Questionnaire (FCQ)​

The severity of subjective cognitive deficits was compared between the groups with and without akathisia2​

The akathisia group (n=25) scored significantly higher on the total FCQ score than the non-akathisia group (n = 42) (P < 0.05)​

In phenomenological subscale scores, the akathisia group had significantly higher scores on various subscales, i.e. ‘anxiety’, ‘disorder of selective attention’, ‘deterioration of discrimination’, ‘perceptual disorder’ and ‘disorder of coping responses’ than the non-akathisia group (P <0.05)​

Background3​
41 stable and chronic patients with schizophrenia, who were receiving maintenance antipsychotic treatment, were rated using the Barnes Akathisia Rating Scale (BARS) for drug-induced akathisia3​

Subjective experiences were evaluated using the Symptom Checklist-90-Revised (SCL-90-R), and cognitive function was assessed using the Wechsler Memory Scale (WMS)​

Analysis of covariance (ANCOVA) with relevant variables as covariates revealed that patients with akathisia (n=17) had significantly higher scores on the depression subscale of the SCL-90-R than those without akathisia (n=24). Patients with akathisia also had significantly lower scores on the mental control subtest of the WMS​

Further analysis using ordinal logistic regression revealed that the depression subscale of SCL- 90-R and the mental control subtest of WMS were significantly associated with the severity of akathisia​

 

  1. Hofer A, et al. J Clin Psychiatry. 2004;65(7):932–9.​
  2. Kim JH, Byun HJ. J Clin Pharm Ther. 2007;32:461–467. ​
  3. Kim et al. Compr Psychiatry. 2002;43(6):456–462​
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Akathisia is associated with emotional symptoms and cognitive impairment​
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Key message: Akathisia is associated with emotional symptoms (e.g. reduced self-esteem, anxiety, depression and paranoid ideation) and cognitive impairment (e.g. problems with mental control, associate learning, perception and coping) ​

Background1​
In a cross-sectional study 80 patients with a schizophrenic disorder (according to ICD-10 criteria) who had an illness duration of over 1 year were investigated, using various rating scales: Positive and Negative Syndrome Scale (PANSS), the St. Hans Rating Scale for EPS, the UKU Side Effect Rating Scale, the Drug Attitude Inventory, and the Lancashire Quality of Life Profile​

Mild to moderate akathisia was reported in 23% of all patients, and there was a significant correlation between akathisia (St. Hans scale) and self-esteem (-0.32**, **p<0.01)​​

Background2​
67 outpatients with schizophrenia receiving stable doses of risperidone or haloperidol were evaluated for akathisia and other extrapyramidal side effects​

Subjective cognitive dysfunction was comprehensively assessed using the Frankfurt Complaint Questionnaire (FCQ)​

The severity of subjective cognitive deficits was compared between the groups with and without akathisia2​

The akathisia group (n=25) scored significantly higher on the total FCQ score than the non-akathisia group (n = 42) (P < 0.05)​

In phenomenological subscale scores, the akathisia group had significantly higher scores on various subscales, i.e. ‘anxiety’, ‘disorder of selective attention’, ‘deterioration of discrimination’, ‘perceptual disorder’ and ‘disorder of coping responses’ than the non-akathisia group (P <0.05)​

Background3​
41 stable and chronic patients with schizophrenia, who were receiving maintenance antipsychotic treatment, were rated using the Barnes Akathisia Rating Scale (BARS) for drug-induced akathisia3​

Subjective experiences were evaluated using the Symptom Checklist-90-Revised (SCL-90-R), and cognitive function was assessed using the Wechsler Memory Scale (WMS)​

Analysis of covariance (ANCOVA) with relevant variables as covariates revealed that patients with akathisia (n=17) had significantly higher scores on the depression subscale of the SCL-90-R than those without akathisia (n=24). Patients with akathisia also had significantly lower scores on the mental control subtest of the WMS​

Further analysis using ordinal logistic regression revealed that the depression subscale of SCL- 90-R and the mental control subtest of WMS were significantly associated with the severity of akathisia​​

  1. Hofer A, et al. J Clin Psychiatry. 2004;65(7):932–9.​
  2. Kim JH, Byun HJ. J Clin Pharm Ther. 2007;32:461–467. ​
  3. Kim et al. Compr Psychiatry. 2002;43(6):456–462​
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Some antipsychotics are associated with high rates of sedating side effects, which can worsen outcomes​
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Key message: The sedative side effects of antipsychotics may have significant consequences for patients, leading to medication non-adherence, increased risk of unintentional injury, and reduced cognitive performance and functional capacity. ​

Background1​
Patients with schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80mg/d (n=125), lurasidone 160mg/d (n=121), quetiapine XR 600mg/d (n=119), or placebo (n=121)​

Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS)​

Functional capacity was assessed by the University of California–San Diego (UCSD) Performance-Based Skills Assessment–Brief Version (UPSA-B) total score​

Cognitive performance was assessed at baseline and week 6 with the CogState Computerized Schizophrenia Battery​

Increase in the ESS item 6 score (‘’dozing when talking’) was associated with a worsening of overall cognitive performance in the quetiapine XR group​

Increase in the ESS total score (reflecting increased sedation) during quetiapine XR treatment was associated with a worsening in the UPSA-B total score​

Background2​
Data were analyzed from a 2007‒2008 nationwide survey of adults who self-reported a diagnosis of schizophrenia and were currently using an antipsychotic medication (N = 876)​

Adherence was defined as a score of zero on the Morisky Medication Adherence Scale.​

A single logistic regression model assessed the relationship between side-effect clusters and adherence.​

The side-effect cluster of sedation/cognition was associated with a lower likelihood of adherence​

Background3​
The study population included patients of 18–64 years of age in a healthcare insurance database with claims from 2001 to 2004 and diagnoses of schizophrenia or affective disorder​

Patients had a prescription for a first-generation antipsychotic (FGA) or second-generation antipsychotic (SGA) ​

Potential somnolence effects were defined as: low (referent) – aripiprazole/ziprasidone; medium – risperidone; high – olanzapine/quetiapine; or any single FGA.​

Among 648 cases and 5214 controls, high-somnolence SGAs were associated with an OR of 1.41 95%CI (1.03–1.93) for risk of unintentional injury​

Background5​
The effect of a single dose of 10 mg olanzapine on healthy volunteers of both sexes was examined using polysomnography and power spectral analysis. The structure and continuity of sleep were unaffected by olanzapine in both sexes​

The clinically important finding was that the same dose of olanzapine in females induced a clear increase in sleep while, in males, the increase was either absent or small, indicating that the effective dose of olanzapine may be lower in females​

  1. Loebel AD et al. CNS Spectr 2014(2;19:197–205. ​
  2. DiBonaventura M et al. BMC Psychiatry 2012;12:20. ​
  3. Said Q et al. Pharmacoepidemiol Drug Saf 2008;17(4):354–364. ​
  4. Seeman MV. Psychiatr Q 2012;83(1):83–89​
  5. Lindberg N et al. Int Clin Psychopharmacol 2002;17(4):177–184.​
  6. Miller DD. Curr Psychiatr. 2007;1;6(8):38. ​
  7. Miller DD, et al. Prim Care Companion J Clin Psychiatry. 2004; 6(suppl 2): 3–7. ​
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Sedation can have a severe impact on many aspects of patient life​
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Key message: Sedation can have a severe impact on many aspects of patient life, such as preventing patients from gaining improvement from treatment, interfering with functioning and quality of life, and reducing adherence to medication. ​

Background7​
Data were analyzed from a 2007‒2008 US survey of adults who self-reported a diagnosis of schizophrenia and were currently using an antipsychotic medication (N = 876)​

Adherence was defined as a score of zero on the Morisky Medication Adherence Scale (MMAS). The MMAS items include the presence or absence of the following non-adherent behaviors: forgetting to take medication, careless at times about taking medication, stopping medication when feeling better, and stopping medication when feeling worse.​

A single logistic regression model assessed the relationship between side effect clusters and adherence.​

The side effect cluster of sedation/cognition (which included (sedation, difficulty thinking or concentrating, sleepiness, and dizziness) was associated with a lower likelihood of adherence (sedation/cognition (OR=0.70, p=0.033))​

  1. Miller DD. Curr Psychiatr. 2007;1;6(8):38.​
  2. Kane JM, Sharif ZA. J Clin Psychiatry. 2008;69(suppl.1):18–31. ​
  3. Lehman AF, et al. [APA Practice Guidelines] 2010. ​
  4. Loebel AD, et al. CNS Spectr. 2014;19(2):197–205. ​
  5. Millier A, et al. J Med Econ. 2014;17(12):853–61. ​
  6. Said Q, et al. Pharmacoepidemiol Drug Saf. 2008;17(4):354–64. ​
  7. DiBonaventura M, et al. BMC Psychiatry. 2012;12:20.​
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Sedation impacts both patient functioning and caregiver burden ​
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Key message: Sedation impacts on patient functioning and caregiver burden, and also can lead to dissatisfaction with medication and discontinuation of treatment. ​

Background​
Review paper entitled ‘Atypical Antipsychotics: Sedation Versus Efficacy’ ​

Many patients with schizophrenia experience disturbances in their sleep–wake cycles, which may be a result of the disease itself, of pharmacotherapy or of a comorbid sleep disorder​

These sleep disturbances can seriously impair patient functioning as well as quality of life​

Most patients develop a tolerance to sedating effects of medication after the acute phase; however, a substantial minority will continue to experience persistent sedation or somnolence, which impacts on quality of life​

Although patients may not be able to accurately describe their symptom as persistent sedation, they may complain that they have no energy, they constantly feel tired or that they cannot think clearly ​

Patients’ families may also indicate that patients do not want to get out of bed or participate in any activities, which may increase the burden on the caregiver​

  1. Kane JM, Sharif ZA. J Clin Psychiatry. 2008;69(suppl. 1):18–31.
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Activating and sedating effects are among the most ‘bothersome’ antipsychotic side effects​
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Key message: Activating (EPS, agitation) and sedating effects are among the most ‘bothersome’ antipsychotic side effects by patients. 86.2% of patients with schizophrenia reported the presence of any side effect. ​

Background​
Data were analyzed from a 2007–2008 US survey of adults who self-reported a diagnosis of schizophrenia and were currently using an antipsychotic medication (n = 876) ​

The presence of side effects was defined as those in which the patient reported they were at least “somewhat bothered”​

Adherence was defined as a score of zero on the Morisky Medication Adherence Scale, and the relationships between adherence and health resource use were also examined​

A majority of patients reported experiencing at least one side effect due to their medication (86.19%), and only 42.5% reported complete adherence ​

Most side effects were associated with a significantly reduced likelihood of adherence​

When grouped as side effect clusters in a single model, extrapyramidal symptoms (EPS)/agitation (odds ratio (OR) =0.57, p=0.0007), sedation/cognition (OR=0.70, p=0.033), prolactin/endocrine (OR=0.69, p=0.0342), and metabolic side effects (OR = 0.64, p = 0.0079) were all significantly related to lower rates of adherence ​

Those who reported complete adherence to their medication were significantly less likely to report a hospitalization for a mental health reason (OR=0.51, p=0.0006), a hospitalization for a non-mental health reason (OR=0.43, p=0.0002), and an emergency room (ER) visit for a mental health reason (OR=0.60, p=0.008)​

​​

  1. DiBonaventura M, et al. BMC Psychiatry. 2012;12:20.​
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Gastrointestinal side-effects can occur with antipsychotics ​
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Key message: Gastrointestinal side-effects, such as constipation, can occur with antipsychotics​

Background2​
Retrospective study in consecutively admitted patients, between 2007–2009 and treated with antipsychotic medication​

Various electronic patient data were linked to evaluate the prevalence and severity of constipation in patients with schizophrenia under routine treatment conditions​

Constipation was defined as have at least one new prescription of a laxative​

Over the 22 months observation period, there were 371 admissions of 273 individual patients with schizophrenia. The mean age of the sample was 40.1 years (range 17–82) and 65.6% were male ​

Over a period of 22 months, 36.3% of patients (n=99) received a pharmacological treatment for constipation at least once. On average, medication for constipation was prescribed for 273 days. Severe cases (n=50), unresponsive to initial treatment, underwent plain x-ray of the abdomen. In 68.4% fecal impaction was found​

A high prevalence of constipation, often severe and needing medical interventions, was confirmed during the study period

  1. MHRA Antipsychotics learning module 2015. Available at http://www.mhra.gov.uk/antipsychotics-learning-module/con155606?useSecon... Last accessed July 2016.​
  2. De Hert M, et al. BMC Gastroenterol. 2011:8;11:17. ​
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Are medication side effects a necessary compromise for continued symptom control?​
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Take home points​
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Selecting suitable treatments for schizophrenia can pose a dilemma for psychiatrists​
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Key message: When selecting treatments for schizophrenia, physicians have to consider many variables, including the patient’s health and lifestyle, co-prescribed medications and previously experienced side effects. ​

Background2​
In selecting treatments for schizophrenia, clinicians have to consider variables related to the patient (e.g. age, history of response), the illness (e.g. duration, symptom type, comorbidity), the medication (e.g. pharmacodynamics, pharmacokinetics, efficacy, tolerability, cost) and the patient’s environment​

The ideal antipsychotic would ​

Reduce excess dopamine levels in the mesolimbic pathway and/or associative striatum to treat psychosis, while maintaining adequate dopamine levels where dopamine is needed​

Cause minimal histaminergic blockade (associated with sedation, weight gain, and metabolic complications), cholinergic blockade (associated with dry mouth, constipation and impaired cognition), and α-adrenergic blockade (associated with orthostasis)​

Have a sufficiently broad gap between efficacy and toxicity, so dosing could be increased as needed without triggering excessive side effects​

Have efficacy for depression and anxiety​

Cause minimal or no EPS and akathisia, and have little risk of tardive dyskinesia (TD)​

Be weight-neutral, cause no metabolic abnormalities, and reverse weight gain and/or lipid abnormalities

  1. Kane JM, et al. Dialogues Clin Neurosci. 2010;12(3):345–357.​
  2. Correll CU. J Clin Psychiatry. 2011;72(suppl.1):9–13. ​
  3. Abidi S, et al. Can J Psychiatry. 2003;48(11):749‒55. ​
  4. Leucht S, et al Lancet. 2013;382(9896):951‒62. ​
  5. Ucok et al. World Psychiatry. 2008;7(1):58‒62. ​
  6. Barnes TR, et al. J Psychopharmacol. 2011;25(2):567‒620.​
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Guidelines for good practice are measurement-based and individualized ​
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Key message: Guidelines for the treatment of schizophrenia recommend regular monitoring for side effects and efficacy of treatment​

Background1​

Symptoms (mental and physical), signs, activities of daily living (ADLs), level of functioning, and side effects are key areas to assess at all phases of the illness​

Collateral information (for example, from family members caregivers and healthcare professionals) is usually essential for a more complete understanding of symptoms, signs and functioning​

Longitudinal follow-up by the same clinician(s) to monitor improvements or worsening is optimal​

The patient’s competency to accept or refuse treatment must be periodically assessed and recorded​

Regular and ongoing evaluations are equally necessary when patients respond to medications, when they fail to respond and when they develop side effects. Standardized scales are useful tools for baseline and later assessments.​

Patients with schizophrenia are at high risk for under-recognition and under-treatment of physical illnesses, therefore specific questioning to uncover physical illnesses is necessary​

Medications must be individualized because the individual response is highly variable​

Patients must be involved in decisions and choices for pharmacotherapy​

  1. Canadian Psychiatric Association. Can J Psychiatry. 2005;50(13;s uppl 1):7S–57S. [CPA Guidelines].​
  2. Lehman AF, et al. [APA Practice Guidelines] 2010. ​
  3. Hasan A, et al. World J Biol Psychiatry. 2013;14(1):2–44 [WFSBP guidelines]. ​
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Shared decision-making and patient centered care lead to better ​ health outcomes​
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Key message: Shared decision-making is a an important process, in which clinicians and patients work together to make decisions about care and treatment, and it can lead to better adherence to treatment and medication​

Background​
Report entitled ‘People in control of their own health and care: The state of involvement’ produced by the King’s Fund. The report concentrates on individuals’ involvement in their own health and care, and the involvement of an individual’s family or other carers.​

Shared decision-making involves the following stages:​

Information exchange, in which the clinician provides reliable, evidence-based information, outlines the options, their likely outcomes, and uncertainties and risks, and the patient shares his or her own knowledge of the condition, and the beliefs, values and preferences that may impact on his or her decision​

Deliberation, during which the options are discussed and preferences are clarified​

Implementation, when the clinician and patient work together to achieve consensus, and the patient’s decisions are then recorded and implemented​

A central part of shared decision-making is the recognition that patients and clinicians bring different, but equally important, knowledge and expertise to the process​

 

  1. Foot C et al. People in control of their own health and care: The state of involvement. The Kings Fund, 2014.​
  2. Coulter & Collins. Making shared decision-making a reality: No decision about me, without me. The King’s Fund, 2011 ​
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Efficacy for positive and negative symptoms are higher priorities than tolerability for physicians when choosing a treatment​
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Key message: Efficacy for positive and negative symptoms are higher priorities than tolerability for physicians when choosing a treatment1​

Background1
In a large, multinational, cross-sectional survey, psychiatrists in the US and five European countries (France, Germany, Italy, Spain and the United Kingdom) who had prescribed antipsychotics for ≥15 patients with schizophrenia within the preceding 3 months, provided data on their patients’ demographic and clinical characteristics, their antipsychotic prescribing practices and drug attributes influencing treatment choice​

Data were collected from 872 physicians on 6,523 patients (85% European, 15% US). Most patients were aged 25–44 years, 63% were men and 66% were outpatients​

As shown on the slide, efficacy for positive symptoms, efficacy for negative symptoms and tolerability were the top three leading reasons for physicians when choosing a particular antipsychotic medication​

Control of positive and negative symptoms was considered to be the leading unmet need of current antipsychotic treatment​​

Note: the data in this slide are from a paper published in 2007. At this time expectations for drugs treating negative symptoms were high2​

  1. Lecrubier Y, et al. Eur Psychiatry. 2007;22(6):371–379. ​
  2. Stahl SM. Acta Psychiatr Scand. 2006;114(5):301–302.​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
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Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​

Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from APA guidelines. ​

Background​
The process for determining pharmacological treatment in the acute phase is shown​

The selection of an antipsychotic medication is frequently guided by the patient’s previous experience with antipsychotics, including the degree of symptom response, the side effect profile (including past experience of side effects) and the patient’s preferences for a particular medication, including the route of administration​

With the possible exception of clozapine for patients with treatment-resistant symptoms, antipsychotics generally have similar efficacy in treating the positive symptoms of schizophrenia​

  1. Lehman AF, et al. [APA Practice Guidelines] 2010.​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
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Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from CPA guidelines. (continued on next slide)​

Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​​

Background​
The process for determining pharmacotherapy in the acute emergent phase for severely aggressive and (or) agitated patients is shown​

Most acutely disturbed individuals with psychosis will respond to the above measures. If no response or patient remains disturbed and a danger to self or others, the guidelines advise seeking a second opinion​

​​

  1. Canadian Psychiatric Association. Can J Psychiatry. 2005;50(13)(suppl 1):7S–57S. [CPA Guidelines].
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​

Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from CPA guidelines. ​

​Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​

Background​
The process for determining pharmacological treatment in the stabilization and stable phase is shown​

All treatment approaches should be tailored to the individual patient, and assessments, pharmacotherapy, and psychosocial interventions should be considered at all stages of treatment. ​

​​

  1. Canadian Psychiatric Association. Can J Psychiatry. 2005;50(13)(suppl 1):7S–57S. [CPA Guidelines]. ​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​​

Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from WFSBP guidelines. ​

​Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​

Background​
The selection of an antipsychotic medication should be guided by the following:​

  • Efficacy/effectiveness and the side effect profile of the antipsychotics ​
  • Patient’s preferences for a particular medication​
  • Intended route of administration​
  • Presence of comorbid medical conditions​
  • Potential interactions with other prescribed medications​
  • Antipsychotic-related side effects​
  1. Hasan A, et al. [WFSBP Guidelines for Biological Treatment of Schizophrenia, Part 1]; World J Biol Psychiatry 2012;13(5):318–378. ​
  2. Hasan A, et al. [WFSBP Guidelines for Biological Treatment of Schizophrenia, Part 2]; World J Biol Psychiatry 2013;14(1):2–44.​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​

​Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from RANZCP guidelines. (continued on next slide)​

Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​

Background​
Psychosocial interventions should be provided​

Mental health service clinicians should communicate with each patient’s GP at least once every 6 months​

Optimal, comprehensive evidenced-based biopsychosocial care should be made available to all people with severe, unremitted psychotic illness​

The clinician needs to work in partnership with primary care physicians and NGOs to ensure physical health and non-clinical needs are adequately addressed​

  1. Galletly C, et al. Aust N Z J Psychiatry. 2016;50(5):410-72.[RANZCP Guidelines] ​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​

Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from RANZCP guidelines. (continued on next slide)​

Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​

Background​
Psychosocial interventions should also be provided​

Mental health service clinicians should communicate with each patient’s GP at least once every 6 months​

Optimal, comprehensive evidenced-based biopsychosocial care should be made available to all people with severe, unremitted psychotic illness​

The clinician needs to work in partnership with primary care physicians and NGOs to ensure physical health and non-clinical needs are adequately addressed

  1. Galletly C, et al. Aust N Z J Psychiatry. 2016;50(5):410-72.[RANZCP Guidelines] ​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​

​Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from RANZCP guidelines. ​

Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered

Background​
Psychosocial interventions should be provided​

Mental health service clinicians should communicate with each patient’s GP at least once every 6 months​

Optimal, comprehensive evidenced-based biopsychosocial care should be made available to all people with severe, unremitted psychotic illness​

The clinician needs to work in partnership with primary care physicians and NGOs to ensure physical health and non-clinical needs are adequately addressed​​

  1. Galletly C, et al. Aust N Z J Psychiatry. 2016;50(5):410-72.[RANZCP Guidelines] ​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​

Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from NICE guidelines. (continued on next slide)​

Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​

Background​
CBT should be delivered on a one-to-one basis over at least 16 sessions​

Family intervention should be carried out for between 3 months and 1 year and include at least 10 sessions​

It is inadvisable to:​

  • Use a loading dose of antipsychotic medication  ​
  • Initiate regular combined antipsychotic medication, except for short periods (for example, when changing medication)​
  1. Kuipers E, et al. NICE Guideline. 2014​​
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The limitations of current treatments can lead to a frustrating experience for everyone affected ​
Slide information
References

Please note, this slide builds​

Key message: The limitations of current treatments can lead to a frustrating experience. Patients may experience a good response but with intolerable side effects, and a lengthy treatment pathway may be required for some patients, as shown by this treatment algorithm adapted from NICE guidelines.​

Note: Select the appropriate local guidelines slides according to the country in which the presentation is being delivered​​

  1. Kuipers E, et al. NICE Guideline. 2014​
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Treatment of schizophrenia needs a rational approach with minimal tolerability issues to optimize patient functioning ​
Slide information
References

Please note, this slide builds​

Key message: There is a need for a rational approach to the management of schizophrenia. Treatment guidelines recommend choosing medication that offers good clinical response without intolerable side effects, as well as regular monitoring of side effects, depending on the antipsychotic.

  1. Lehman AF, et al. [APA Practice Guidelines] 2010.​
  2. Kuipers E, et al. NICE Guideline. 2014​
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Medication side effects can impair workplace performance and act as a barrier to entering or returning to work​
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References

Please note, this slide builds​

Key message: Medication side effects can impair workplace performance act as a barrier to entering or returning to work. The stigma resulting from medication side effects leads to perceptions of laziness and addiction problems in patients with schizophrenia, and this stigma leads some patients to reduce or skip their medication. ​

Background1​
A semi-structured focus group was conducted in Slovenia in 10 inpatients (four women and six men aged 30–61 years) with schizophrenia or schizoaffective disorder with severe and remitting mental illness treated with antipsychotic medication ​

The aim was to obtain their personal views on how side effects of antipsychotic drugs affect their everyday lives and contribute to the stigmatization because of mental illness ​

Open ended questions were posed about the influence of side effects on illness disclosure, work performance, family relationships and treatment adherence were included in the questionnaire ​

The patients felt most stigmatized in areas of employment and occupation​

They repeatedly skipped or discontinued regular medication because of  side effects​

Background2​
Report highlights the barriers experienced by people with schizophrenia in Germany to entering and remaining in the open labor market​

In order to gain an in-depth understanding of the impact of how the structural, economic, clinical and attitudinal barriers to employment affect people with schizophrenia, previous studies (including a similar piece of research we conducted in the UK) were reviewed, and in-depth interviews with people with lived experience of schizophrenia were conducted​

The opinions of professionals with expertise in the provision of health, social care and vocational rehabilitation, policy experts, and employers were also sought​

Schizophrenia often has considerable influence on an individual’s employment opportunities​

  • The symptoms of the illness, side effects of the treatment and the possibility of relapse may make entering or returning to work difficult​
  • This is exacerbated by the onset of schizophrenia commonly occurring during the teens and early twenties – interrupting education, early career and the transition to independent living​
  • Illness onset can have significant implications for an individual’s, employment prospects, with employers searching out employees with the best job history and qualifications​
  • Similarly, the gaps in employment history caused by period of ill health may reduce an individual’s attractiveness to employers compared with other candidates​​

  1. Novak L, Švab V. Psychiatr Danub. 2009;21(1):99–102. ​
  2. Steadman K, et al. Working with Schizophrenia: Employment, recovery and inclusion in Germany. The Work Foundation. 2015.​
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Negative feelings towards medication are associated with lower scores in both affect and self-esteem​
Slide information
References

Key message: Negative feelings towards medication are associated with lower scores in both affect and self-esteem​

Background​
Cross sectional study investigating (n=80) patients (aged 19–60) with schizophrenic disorder according to ICD-10 criteria who had a duration of illness over 1 year and whose discharge from an inpatient unit had been at least six weeks earlier​

The aim was to investigate the relationship between antipsychotic induced side effects and subjective QoL​

Various rating scales were used: Positive and Negative Syndrome Scale (PANSS), St. Hans Rating Scale for Extrapyramidal Syndromes, the UKU Side Effect Rating Scale, the Drug Attitude Inventory and the Lancashire Quality of Life Profile​

The combined effects of sociodemographic variables, psychopathology, type of antipsychotic medication, antipsychotic-induced side effects and attitude toward medication on QoL were analyzed with multiple linear regression analysis (summarized in the table on the slide) 

 

  1. Hofer A, et al. J Clin Psychiatry. 2004;65(7):932–939.​
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Side effects of antipsychotic medications are significantly associated with lower adherence​
Slide information
References

Key message: Medication side effects are highly prevalent and significantly associated with medication nonadherence​

Background​
Data were analyzed from a 2007–2008 nationwide survey of adults who self-reported a diagnosis of schizophrenia and were currently using an antipsychotic medication (N= 876)​

Adherence to medications was assessed using the four-item Morisky Medication Adherence Scale (MMAS). Adherence was defined as a score of zero on the Morisky Medication Adherence Scale.​

Medication side effects were self-reported​

Most of the side effects assessed were significantly associated with a decreased likelihood of medication adherence. Sensitivity analyses using the more restrictive definition of side-effect presence did not change overall model results with respect to significance or magnitude​

EPS/agitation-related side effects were the most strongly associated with nonadherence, and were commonly reported​

Side effects of antipsychotic medications are highly prevalent and significantly associated with lower adherence, which is associated with increased healthcare resource use​

  1. DiBonaventura M, et al. BMC Psychiatry. 2012;12:20.​
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Emotional and practical burdens of schizophrenia on families are intertwined​
Slide information
References

Key message: Emotional and practical burdens of schizophrenia on families are intertwined with feelings of frustration, anxiety, low self-esteem and helplessness occurring in the relatives of patients. ​

Background​
This study set out to explore the relationship between stigma, accessibility of mental health facilities and family burden through individual interviews of patients’ relatives ​

Ten interviewees from two out-patient psychiatric clinics were recruited and interviewed. Each interviewee had at least one family member receiving out-patient psychiatric services. ​

A combination of unstructured and semi-structured interviewing was used to interviewees’ perceptions of burden, the importance they attached to different issues and the feelings they had about the illness ​

Data analyses of the transcripts and interview notes (using the interpretive interview analysis method) showed that much of the burden on the patient’s family was related to stigma and to lack of mental health and rehabilitation services​

Consequences of this burden included social isolation of the families, difficulties experienced by patients when trying to obtain competitive employment and financial difficulties​

Subjective burden resulting from social stigma included frustration, anxiety, low self-esteem and helplessness ​

The objective and subjective burdens on families were intertwined, for example when relatives had difficulty meeting practical demands, they would most likely also have had a negative emotional response; such an emotional response would in turn affect their ability to cope with practical demands. (i.e. objective and subjective burden can augment each other)​

  1. Tsang HW, et al. Int J Rehabil Res. 2003;26(2):123–30.​
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Take home points​
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Can advances in the understanding of receptor ​ pharmacology avoid the current treatment compromises? ​ ​
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Take home points​
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Antipsychotics have a rich receptor pharmacology, which contributes to efficacy as well as side effects​
Slide information
References

Key message: Atypical antipsychotics differ in their tendency to induce a variety of side effects, such as weight gain and other metabolic abnormalities, extrapyramidal symptoms (EPS), sedation, hyperprolactinaemia and QT prolongation.​

Background​
Antipsychotics with a stronger relative affinity for a particular receptor system over the D2 receptor are likely to induce side effects associated with the blockade of that receptor system1​

The side effects associated with blockade receptors (see table) can occur either within the dose spectrum required for antipsychotic efficacy or not, and can include weight gain and other metabolic abnormalities, extrapyramidal symptoms (EPS), sedation, hyperprolactinaemia, and QT prolongation1​

Whenever the Ki (inhibitor constant) value is lower (signifying stronger affinity) for a receptor system than for dopaminergic receptor i.e. stronger relative affinity, a side effect associated with the blockade of this receptor is likely to occur as part of antipsychotic treatment1 ​

Newer antipsychotics, which act as partial agonists at the D2 receptor, regulate dopamine activity and minimize the potential for extrapyramidal symptoms and prolactin elevation2,3​

  1. Correll CU. Eur Psychiatry. 2010;25(suppl. 2):S12–S21. ​
  2. Stahl SM. CNS Spectr. 2013;18(6):285‒288. ​
  3. Leucht S et al. Lancet. 2013;382(9896):951‒962. ​
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A key factor for D2 partial agonism is the determination of the optimal level of intrinsic activity at the receptor ​
Slide information
References

Please note, this slide builds​

Key message: A key factor for D2 partial agonism is the determination of the optimal level of intrinsic activity at the receptor; too high and there is a potential lack of antipsychotic effect and increased risk of side effects (e.g. nausea, vomiting, insomnia and motor effects); too low and there is a potential increased risk of extrapyramidal symptoms and raised prolactin levels. 

 

  1. Citrome L, et al. Expert Rev Neurother 2015;15(10):1219–1229.​
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Take home points​
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Summary​
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Summary​
Slide information
References

Please note, this slide builds. ​​

Optimal patient functioning and improved quality of life are important treatment goals at all stages of schizophrenia management1,2​

Functional impairment may result from an insufficient treatment effect2–4​

Sedating or activating side effects can prevent patients from functioning at their optimal level and negatively impact their quality of life5–8​

The side effects associated with current treatments are often seen as a necessary compromise for continued symptom control9–12,3​

The limitations of current treatments, especially the side effect burden, and the impact on functional domains can be frustrating for everyone and decrease quality of life14–18 ​

  1. Hasan A, et al. World J Biol Psychiatry. 2013;14(1):2–44 [WFSBP guidelines]. ​
  2. Lehman AF, et al. [APA Practice Guidelines] 2010. ​
  3. Lecrubier Y, et al. Eur Psychiatry. 2007;22(6):371–379​
  4. Schennach R, et al. Eur Arch Psychiatry Clin Neurosci. 2015;265(2):107–16.​
  5. Bobes J, et al. Dialogues Clin Neurosci. 2007;9(2):215–26.​
  6. Kane JM, Sharif ZA. J Clin Psychiatry. 2008;69(suppl 1):18–31​
  7. Loebel AD et al. CNS Spectr 2014;19(2):197–205​
  8. Hofer A, et al. J Clin Psychiatry. 2004;65(7):932–9​
  9. Leucht S, et al Lancet. 2013;382(9896):951‒962​
  10. Ucok et al. World Psychiatry. 2008;7(1):58‒62.​
  11. Barnes TR, et al. J Psychopharmacol. 2011;25(5):567–6203​
  12. Abidi S, et al. Can J Psychiatry. 2003;48(11):749‒755​
  13. Morgan VA, et al. Aust N Z J Psychiatry. 2012;46(8):735752​
  14. Awad AG, Voruganti LN. Pharmacoeconomics. 2008;26(2):149–62.​
  15. Naber D, Kasper S. Int J Psychiatry Clin Pract. 2000;4(1):25‒34. ​
  16. Caqueo-Urízar A, et al. Health Qual Life Outcomes. 2009:11;7:84.​
  17. National Alliance on Mental Illness (NAMI). Schizophrenia: Public Attitudes, Personal Needs: Views From People Living With Schizophrenia, Caregivers, and the General Public. 2008;NAMI, Arlington, VA.​
  18. Tsang HW, et al. Int J Rehabil Res. 2003;26(2):123–30.​
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