Clark 1975.
Methods | Allocation: random ‐ pre‐randomised list, blocks of 3, provided by drug company. Blinding: double ‐ identical capsules. Duration: 4 weeks. Setting: single centre. | |
Participants | Diagnosis: schizophrenia, confirmed by research psychiatrists. N=42. Age: range 21‐57 years. Sex: 21 M, 16 F, 6 unreported. History: ill > 2 years, healthy, not able to bear children. | |
Interventions | 1. Loxapine: dose 100mg/day, mean 71mg/day. N=15. 2. Trifluoperazine: dose 50 mg/day, mean 36 mg/day. N=14. 3. Placebo. N=13. Short acting sedatives and antiparkinsonian medication as required. | |
Outcomes | Global effect (CGI‐I, CGI‐S, use of additional sedation).
Adverse effects.
Leaving the study early.
Laboratory tests.
Physiological measures (ECG, weight). Unable to use ‐ Efficacy: (analysis of covariance ‐ no usable data). Mental state: BPRS (no SD). Behaviour: NOSIE (no usable data). Physiological measures: BP, pulse (no data). |
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Notes | 6 people removed from analysis but original group of allocation reported so ITT analysis possible. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |