Pimozide 1971.
Study characteristics | ||
Methods | Randomisation: randomised, no further details. Allocation: procedure not described. Blinding: double‐blind, no further details. Duration: 12 weeks. Design: parallel. Location: single‐centre. Setting: inpatients. | |
Participants | Diagnosis: chronic schizophrenia (clinical diagnosis), receiving maintenance treatment. N = 20. Gender: only male participants. Age: 42.6 years. History: duration stable‐n.i., duration ill‐ n.i., mean duration of hospitalisation‐ n.i., number of previous hospitalisations‐ n.i., age at onset‐ n.i., severity of illness‐ mean BPRS total score 34.6, mean CGI‐S total score 3.73, baseline antipsychotic dose‐ n.i., remission at baseline‐ 40% were in remission at baseline (CGI‐S defined). | |
Interventions | 1. Drug: Pimozide. N = 10 Flexible dose. Mean dose: 40 mg/day. 2. Placebo: duration of taper: abrupt withdrawal. N = 10. Rescue medication: n.i. |
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Outcomes |
Examined Leaving the study early. Global state ‐ number of participants improved (CGI‐I defined). Global state ‐ number of participants in remission (CGI‐S defined). Adverse events. Unable to use/Not included Mental state: BPRS (no predefined outcome of interest) Behavior: NOSIE (no predefined outcome of interest). |
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Notes | Sponsored by McNeil Laboratories. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, 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, no further details. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, no further details. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, no further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only study completers were used in the final analysis, but as there was only one dropout (in the drug arm, before receiving the first dose of medication) this was not necessarily a problem. |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
Other bias | High risk | The pimozide doses (40 mg/day) were very high for current standards. |