Gallant 1967.
Methods | Randomisation: “randomly assigned”. Blinding: double‐blind. Duration: 30 days. Design: parallel (three‐arm study with chlorpromazine as third treatment group). Location: Southeast Louisiana Hospital, Mandeville, Louisiana. Setting: inpatients. |
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Participants | Diagnosis: schizophrenia. N = 39. Gender (including participants of the chlorpromazine study group, N = 58): 30M, 28F. Age (including participants of the chlorpromazine study group, N = 58): mean 33.4 years. History: duration stable: not indicated, duration of illness: not indicated, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated. |
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Interventions | 1. Haloperidol: fixed/flexible dose: not indicated, dose range: maximum dose 16 mg/day, mean dose: not indicated. N = 19. 2. Trifluperidol: fixed/flexible dose: not indicated, dose range: maximum dose 4 mg/day, mean dose: not indicated. N = 20. Rescue medication: “use of anti‐parkinson medication (Artane) prophylactically for all subjects throughout the study”. Administration of benztropine (Cogentin, 2 mg i.m.) was allowed. |
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Outcomes | Examined: Clinically important response to treatment: Global Rating of Improvement. Adverse effects: at least one movement disorder, dyskinesia, hypotension. Unable to use: Mental state general: Beckomberga Rating Scale (no SDs available and no imputation method could be applied). Behaviour: MACC Behavioral Adjustment Scale (no raw data available). Behaviour: Tulane Test Battery (no raw data available). |
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Notes | In a third study arm of this trial chlorpromazine was investigated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Randomly assigned”. No further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. “All drugs were supplied in identical capsules and were dispensed from individual medication bottles which were prepared and coded prior to the study.” |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The study did not address this outcome; insufficient information to permit judgment concerning incomplete outcome data. |
Selective reporting (reporting bias) | High risk | Outcome data were not fully addressed (no raw data for the MACC Behavioral Adjustment Scale and the Tubane Test Battery; no SDs were provided for the Beckomberga Scale). Adverse effects reporting was incomplete. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |