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. 2016 Apr 14;2016(4):CD004161. doi: 10.1002/14651858.CD004161.pub2

Gaebel 2010*.

Methods Allocation: random.
Blinding: open‐label.
Duration: 2 year.
Design: parallel.
Setting: international, multi‐centre, 25 countries (Europe).
Participants Diagnosis: schizophrenia or schizoaffective (DSM‐IV).
N = 710.
Age: ≥ 18 years, mean 40.6 +/‐ 12.5 in depot risperidone group; 42.6 +/‐ 13.1 quetiapine group; 40.9 +/‐ 12.94 in aripiprazole group.
Sex: 442 M, 270 F.
History: symptomatically stable.
Included: switching therapy because of insufficient symptom control with current treatment, side effects or patient request; symptomatically stable‐ using stable dose of antipsychotic for ≥ 4 weeks and living in same residence for ≥ 30 days.
Excluded: previous non‐response to risperidone, quetiapine or ≥ 2 antipsychotics despite adequate drug plasma levels; DSM IV axis I diagnosis other than schizophrenia or schizoaffective disorder; phenylketonuria or hypersensitivity to risperidone or quetiapine; drug or alcohol dependence during preceding 1 month; acute risk of suicide or history of suicide attempt.
Consent and ethics: study conducted in accordance with guidelines of the International Conference on Harmonisation for Good Clinical Practice. Study protocol and consent were approved by ethics committees/ institutional review boards; informed consent obtained from all participants before enrolment.
Interventions 1. Risperidone depot: 25‐50 mg IM every 2 weeks, n = 329.
2. Quetiapine oral: 25 mg twice a day: day 1, 300‐ 400 mg by day 4, max 750 mg a day, n = 337.
3. Aripiprazole oral: 10‐30 mg per day, n = 46.
Outcomes Adverse events.
Leaving the study early.
Death.
Unable to use ‐ (all due to high attrition)
Time to relapse.
Global state: CGI.
Mental state: PANSS.
Functioning assessment: SOFAS.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stratified randomisation according to previous treatment.
Allocation concealment (selection bias) Unclear risk No details given.
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label study. No evidence for any rater blinding‐ follow‐up methods differed between treatment groups (phone calls for quetiapine group and in person with depot risperidone).
Incomplete outcome data (attrition bias) 
 All outcomes High risk High attrition: treatment completed by n = 151/329 in risperidone depot; n = 120/337 oral quetiapine; n = 9 oral aripiprazole. Total follow‐up of n = 280/710 (39%) ‐ only leaving study early and adverse event data used.
Selective reporting (reporting bias) Unclear risk Some outcomes comprising relapse are not reported on their own.
Other bias High risk Funding: study sponsored by Janssen‐Cilag Medical Affairs EMEA.