Various drugs 1962b.
Study characteristics | ||
Methods | Randomisation: randomised, no further details. Allocation: psychiatrist without contact to the participants held the key and filled the medication containers. Blinding: double‐blind, exact placebo replicas. Duration: ~ 43 weeks. Design: parallel. Location: single‐centre. Setting: outpatient. | |
Participants | Diagnosis: schizophrenia without positive symptoms (clinical diagnosis). N = 43. Gender: 16 men, 27 women. Age: typically 40 to 50 years. History: duration stable‐ out of hospital for at least a year (typically 2 to 4 years), duration ill‐ n.i., number of previous hospitalisations‐ typically 2‐3, age at onset n.i., severity of illness n.i., but no positive symptoms at baseline, baseline antipsychotic dose‐ maximum 300 mg chlorpromazine per day. |
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Interventions | 1. Drug: various phenothiazines, mainly chlorpromazine. Fixed/flexible dose: flexible. Allowed dose range: not limited, but complete discontinuation was not allowed. Mean dose: 150 mg/day to 200 mg/day chlorpromazine. N = 24. 2. Placebo: duration of taper: 0 days. N = 19. Rescue medication: not allowed. |
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Outcomes |
Examined Relapse: clinical judgement. Service use: number of participants rehospitalised. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no further details. |
Allocation concealment (selection bias) | Low risk | Psychiatrist without contact to the participants held the key and filled the medication containers. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, exact placebo replicas. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, exact placebo replicas. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, exact placebo replicas. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear ‐ whether participants discontinued the study prematurely was not reported. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | High risk | Some placebo participants continued to take medication, study terminated early. |