Petit 1996.
| Methods | Allocation: randomised ‐ no further details.* Blinding: double ‐ identical and dummy capsules. Duration: 8 weeks ‐ preceded by omission of last depot. Intention‐to‐treat analysis: last observation carried forward. Setting: 13 French hospitals. Power calculation: able to demonstrate an 8.2 difference between treatment groups on BPRS. | |
| Participants | Diagnosis: schizophrenia (DSM‐III‐R). Inclusion criteria: 4+ on CGI, not physically ill, no substance abuse. N=126. Age: range 18‐68 years, mean ˜39. Sex: 63 M, 63 F.* History: currently acutely ill, in hospital, overall duration ill 6 months to 41 years. | |
| Interventions | 1. Zotepine: dose 150‐300 mg/day. N=63. 2. Haloperidol: dose 10‐20 mg/day. N=63. |
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| Outcomes | Mental state (50% reduction in BPRS).
Leaving the study early.
Adverse events. Unable to use ‐ Global improvement (CGI ‐ no mean). Mental state (SANS ‐ no mean). Adverse events: (AIMS, SAS ‐ no SD). ECG (no data). Pulse (no SD). |
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| Notes | * Haloperidol group had twice as many women as zotepine group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |