Gaebel 2010*.
Methods | Allocation: random. Blinding: open‐label. Duration: 2 year. Design: parallel. Setting: international, multi‐centre, 25 countries (Europe). |
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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. |
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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. |
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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. |
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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. |