Van Der Velde 1975.
Methods | Allocation: randomised ‐ no further details. Blinding: double ‐ identical capsules. Duration: 6 weeks ‐ preceded by 14 day drug free period. Setting: single centre. | |
Participants | Diagnosis: schizophrenia, acute or acute exacerbation (by 2 psychiatrists & principal investigator). N=82. Age: mean ˜ 27 years. Sex: 43 M, 33 F, 6 not reported. Exclusion: not completing 2 weeks of study medication. History: 18/82 first episode, rest onset in last 6 years. | |
Interventions | 1. Loxapine: dose range 50‐150 mg/day. N=26.
2. Thiothixene: dose range 20‐60 mg/day. N=28.
3. Placebo. N=28. Antiparkinsonian drugs and chlorayl hydrate as required. |
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Outcomes | Dropped from analysis.
Leaving the study early.
Adverse effects.
Laboratory tests. Unable to use ‐ Efficacy: (variance analyses ‐ no usable data). Global effect: CGI (no usable data). Mental state: BPRS (no usable data). Behaviour: NOSIE (no usable data). Adverse effects: Use of antiparkinsonian drugs (no data). Physiological measures: BP, EEG, pulse, temperature, weight (no data). |
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Notes | 6 people withdrawn from analyses ‐ original group clear so ITT analysis possible. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |