Various drugs 1960.
Study characteristics | ||
Methods | Randomisation: random, no further details. Allocation: procedure not described. Blinding: double‐blind, unidentifiable capsules. Duration: 6 months. Design: parallel. Location: single‐centre. Setting: outpatient. | |
Participants | Diagnosis: chronic psychotic patients (mainly schizophrenia, clinical diagnosis). N = 144. Gender: n.i.. Age: n.i.. History: duration stable‐ "observed on the same drugs for 4.5 months”, duration ill‐ n.i., number of previous hospitalisations‐ n.i., age at onset‐ n.i., severity of illness‐ n.i., baseline antipsychotic dose‐ n.i.. |
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Interventions | 1. Drug: continuation of antipsychotic taken before the study ‐ Fixed/flexible dose: unclear. Allowed dose range: unclear. Mean dose: n.i.. N = 46. 2. Placebo: duration of taper: "4 weeks to five months, usually 2 months”. N = 98. Rescue medication: n.i.. |
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Outcomes |
Examined Relapse: clinical diagnosis. Unable to use/Not included Social adjustment: (not reported for the randomised participants). Rehospitalisation (unclear numbers). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random, no further details. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, unidentifiable capsules. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, unidentifiable capsules. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, unidentifiable capsules. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Whether participants left the study early is unclear. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | High risk | In case of relapse the blind was broken. |