Various drugs 1961.
Study characteristics | ||
Methods | Randomisation: random, no further details. Allocation: only the hospital pharmacist had the code on what medication the patient was on. Blinding: double‐blind, identical capsules, each participant had his own container. Duration: 16 weeks. Design: parallel. Location: single‐centre. Setting: inpatient. | |
Participants | Diagnosis: schizophrenia (clinical diagnosis), all withdrawn of subject to periodic disturbances, all needed supervision or management. N = 80. Gender: 80 men. Age: younger than 55 years, mean 40.6 years. History: duration stable‐ n.i. ("participants had attained and maintained some degree of improvement”), duration ill‐ n.i., but mean duration of current hospitalisation 10 years, number of previous hospitalisations‐ mean 1.6, age at onset‐ n.i., severity of illness‐ n.i., but "most required closed ward care”, median baseline antipsychotic dose‐ chlorpromazine 475 mg/day (N = 30), mepazine 200 mg/day (N = 35), trifluoperazine 30 mg/day (N = 6), prochlorpromazine (N = 2, dose not indicated), combinations of drugs (N = 7, doses not indicated) |
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Interventions | 1. Drug: chlorpromazine; flexible dose; allowed dose range 200 mg/day to 1000 mg/day; mean dose: 894 mg/day (here mean maximum dose); N = 20 2. Drug: trifluoperazine; flexible dose; allowed dose range 10 to 50 mg/day; mean dose: 29 mg/day (here mean maximum dose); N=20 3. Drug: thioridazine; flexible dose; allowed dose range 200 mg/day to 1000 mg/day; mean dose: 958 mg/day (here mean maximum dose); N = 20 4. Placebo: duration of taper: 0 days; N = 20 Rescue medication: phenobarbital and bentropine methansulfonate, no additional antipsychotic drugs |
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Outcomes |
Examined Relapse: worsening of global state Leaving the study early. Global state ‐ number of participants improved (clinical judgement, categories comparable to CGI). Adverse effects: clinical interview, number of participants receiving antiparkinson medication Unable to use/Not included Behaviour: Manifest Behaviour Scale (no SD/no predefined outcome of interest) Personality traits: Minnesota Multiphasic Personality Inventory (MMPI) (no SD/no predefined outcome of interest) |
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Notes | The results of all drug groups were pooled. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random, no further details |
Allocation concealment (selection bias) | Low risk | Only the hospital pharmacist had the code on what medication the patient was on |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, identical capsules, each participant had his own container. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, identical capsules, each participant had his own container. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, identical capsules, each participant had his own container. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 3 out of 80 participants left the study early and the reasons were well described. |
Selective reporting (reporting bias) | Low risk | No selective reporting. |
Other bias | Low risk | No evidence for other bias. |