Chouinard 1977.
Methods | Allocation: randomised. Blindness: double. Duration: 12 weeks, preceded by 2 weeks fixed daily dose of 125 mg chlorpromazine. Setting: single‐centre, Hôpital St‐Jean‐de‐Dieu, Montréal and Hôpital St‐Charles, Joliette (Canada). | |
Participants | Diagnosis: chronic schizophrenia.
N = 54.
Age: mean ˜ 46 years.
Sex: 27 F, 27 M.
History: all participants previously receiving antipsychotic medication (not specified); mean hospitalisations 13.35. Included: age 20 to 60 years; primary diagnosis of schizophrenia. Excluded: organic heart disease; physical illness/ chronic or acute brain syndrome; IQ lower than 70; alcoholism; epilepsy; drug addiction; electrolyte abnormalities. Consent: all participants gave informed consent after purpose of the study and possible side effects had been explained. |
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Interventions | 1. Perphenazine (Trilafan) 20mg/ day, n = 18.
2. Placebo: 5 tablets a day, n = 18. [3. Perphenazine 20 mg/day and amitriptyline 125 mg/day, n = 18 ‐ not included in data and analysis, combined with anti‐depressant]. |
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Outcomes | Leaving the study early.
Adverse events: use of antiparkinsonian medication.
Physical tests: ECG abnormalities (primary outcome). "Intensified psychopathological condition" ‐ resulting in hop. |
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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 | No further details. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double: ECG readings (primary outcome) taken by cardiologist unaware “as to factors under study” (p.952). Drugs were administered in identically‐appearing tablets. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Follow‐up ‐ N = 38 (70%), with equal amount of males (n = 19) and females (n = 19) remaining. N = 13 placebo participants were excluded from study because of intensified psychopathological condition resulting in hospitalisation or chlorpromazine use. N = 1 perphenazine and n = 2 perphenazine‐amitriptyline participants were hospitalised and excluded from study. |
Selective reporting (reporting bias) | Low risk | None detected. |
Other bias | Unclear risk | Funding: unclear. Raters: not stated to be independent of treatment. |