Tandon 2006.
Methods | Allocation: random. Blindness: open label. Duration: 8 weeks. Design: prospective, parallel group. Location: multicentric in USA. | |
Participants | Diagnosis: Schizophrenia or schizoaffective disorder (DSM IV), required initiation of antipsychotics, antipsychotic switch clinically appropriate. N = 1599. Age: 18‐75 years. History: duration of illness not reported, age at onset not reported. Setting: Outpatients. |
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Interventions | 1. Aripiprazole: 10 mg‐30 mg/day (mean 19.9 mg/day); N = 1295. 2. Other antipsychotic: recommended dose; N = 304. | |
Outcomes | Global state: CGI‐I. Adverse effects: At least one adverse effect, extrapyramidal adverse effects, gastrointestinal disorders, sleep disturbances. Others: POM. | |
Notes | Primary goal was evaluating the effectiveness of aripiprazole in general psychiatric outpatient practice setting. The other antipsychotic treatment group was primarily included for interpreting the safety data and not for direct comparison. Unable to use data from CGI‐I and POM. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 4:1 computer‐generated randomised schedule using Interactive Voice Response System. |
Allocation concealment (selection bias) | High risk | Open label. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | LOCF method used to account for people leaving the study early. |
Selective reporting (reporting bias) | High risk | Adverse events were reported if they were > 5%. Scales if used were not reported. |
Other bias | High risk | Industry sponsored. |