Gerlach 1974 (H).
Methods | Allocation: randomised. Blindness: varied with outcome. Design: cross‐over. Duration: 28 weeks; first arm 82 days (preceded by 5 to 51 day washout). Setting: inpatients. | |
Participants | Diagnosis: schizophrenia ‐ paranoid (N=11), hebephrenic (N=7), catatonic (N=2). No diagnostic criteria. N=20. Sex: male. Age: range 18 to 60 years. History: illness duration 2 to 33 years. | |
Interventions | 1. Clozapine: dose initially 50 mg/day, median at day 82, 200 mg/day; followed by haloperidol after a second wash‐out period. N=10.
2. Haloperidol: dose initially 1 mg/day, median at day 82, 10 mg/day; followed by clozapine after second wash‐out period. N=10. Procyclidine, biperiden & nitrazepam as needed. |
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Outcomes | Death.
Relapse.
Leaving the study early.
Global effect: non‐blind clinical evaluation.
Adverse effects: non‐blind check list.
ECG & laboratory tests. Unable to use ‐ Mental state: blind 18‐item BPRS (no SDs). |
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Notes | Jadad score 1. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomised ‐ no details |
Allocation concealment? | Unclear risk | No details |
Blinding? All outcomes | Unclear risk | Participants aware of treatment; assessors were blind, untested |
Incomplete outcome data addressed? All outcomes | Unclear risk | No details |
Free of selective reporting? | Unclear risk | No details |
Free of other bias? | Unclear risk | Unclear |