Schiele 1961.
Methods | Allocation: randomly assigned (held by the pharmacist). Blindness: double (identical capsules, coded bottles). Design: 4 parallel groups, single centre. Duration: 16 weeks (in strict double‐blind conditions) + 22 weeks, no washout period. Analysis: intention to treat. Country: USA. | |
Participants | Diagnosis: schizophrenia, no further details. N=80. Age: mean 40.6 years. Sex: males. Setting: hospital. History: chronic (average hospitalisation 10 years). Excluded: people > 55 years and organic factors. Included: inadvertently 3 with lobotomies (2 in the thioridazine group and other in the chlorpromazine). | |
Interventions | 1. Trifluoperazine: 10‐50 mg/day, maximum 35 mg, 12 received less than the maximum. N=20. 2. Thioridazine: 200‐1000 mg/day, maximum 958 mg, 3 received less than the maximum. N=20. 3. Chlorpromazine: 200‐1000 mg/day, maximum 894 mg/day, 3 received less than the maximum. N=20. 4. Placebo: 2‐10 capsules. Occasional additional medication, phenobarbital and benzotropine methansulfonate. | |
Outcomes | Global state: (Clinical Evaluation).
Side effects.
Leaving the study early.
Use of antiparkinson agents. Unable to use ‐ Behaviour: (Behaviour rating scale ‐ no SD). Mental state: (MMPI ‐ only 43 patients took the tests). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |