Chouinard 1995.
Methods | Allocation: "randomly assigned", not described
Blindness: "double blind", partially described
Design: post hoc analysis of parallel, 6‐group RCT
Setting: inpatients, Canada Duration: 8 weeks |
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Participants | Diagnosis: chronic schizophrenia (DSM‐III R criteria)
N = 135
Age: mean 39 years, range 19‐60 years
Sex: 34 men and 14 women History: duration TD not reported; the most common pre‐study medications were haloperidol, procyclidine, lorazepam, benztropine and chlorpromazine; the most commonly used depot antipsychotic agents were haloperidol decanoate, fluphenazine decanoate, flupenthixol decanoate and pipothiazine palmitate. |
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Interventions | Mean duration of washout phase 6 days. 1. Risperidone: dose 2 mg/d for 8 weeks. N = 8 2. Risperidone: dose 6 mg/d for 8 weeks. N = 6 3. Risperidone: dose 10 mg/d for 8 weeks. N = 6 4. Risperidone: dose 16 mg/d for 8 weeks. N = 11 5. Haloperidol: dose 20 mg/d. N = 6 6. Placebo: N = 11 "At the time of selection, all psychotropic and antiparkinsonism medications were discontinued"; "no other psychotropic medication was administered except for chloral hydrate or a benzodiazepine if a sedative/hypnotic was required.", "An antiparkinsonian medication (biperiden or procyclidine) was given in case of the emergence of clinically significant drug‐induced parkinsonism and dystonia" |
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Outcomes | Adverse events: use of antiparkinsonism medication Unable to use (data does not have variability measures, and only reports differences from baseline to worst scores) ‐ ESRS: dyskinesia symptoms total score, CGI severity dyskinesia, buccolinguomasticatory factor, choreoathetoid factor |
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Notes | Sponsorship source: not reported. Study author kindly replied to our request for data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned", details not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "identical tablets" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of raters not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 33% of participants terminated the study early due to insufficient therapeutic response. All early terminations were included in the ITT analysis |
Selective reporting (reporting bias) | High risk | Outcomes not fully reported |
Other bias | High risk | Subgroup with TD |