Takahashi 1982.
Methods | Allocation: randomised. Blindness: double (implied). Duration: 12 weeks. Setting: inpatient, multi‐centre (31 psychiatric institutions), Japan. | |
Participants | Diagnosis: schizophrenia (n = 127 hebephrenic, n = 24 catatonic, n = 38 paranoid, n = 4 hebephrenic‐catatonic, n = 2 hebephrenic‐paranoid, n = 1 schizoaffective, n = 2 undifferentiated).
N = 205*.
Age: 13 ‐ 60 years.
Sex: no details.
History: inpatient. Included: not described. Excluded: early stages of gestation; severe liver, kidney, cardiovascular and blood diseases; idiosyncrasy to psychotropic drugs; consciousness disturbances or vascular collapse or conditions under strong effects of neuro‐depressants; organic brain disorders; those patients whose conditions in the judgement of the attending physician would make it unlikely that they could tolerate the study treatment. Consent: informed consent obtained from each participant and guardian prior to the trial. |
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Interventions | 1. Perphenazine: 4 mg per tablet + placebo tablet matching to the timiperone tablet, initially two or three tablets daily, afterwards individualised according to symptoms and side effects, maximum daily dose was 12 tablets, n = 99.
2. Timiperone: 1 mg per tablet + placebo tablet matching to the perphenazine tablet, initially two or three tablets daily, afterwards individualised according to symptoms and side effects, maximum daily dose was 12 tablets, n = 99. Additional medication: mild hypnotics and anti‐parkinsonian drugs ‐ no further details. |
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Outcomes | Leaving the study early.
Global state: no better or worse.
Adverse events. Unable to use ‐ Mental state: Keio University Brief Psychiatric Rating Scale (unpublished scale). |
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Notes | *Only 198 participants were evaluated and described. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised: quote, "participants were assigned randomly" (p258). 'Randomised code' referred to, which was broken only at the end of treatment period. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind: implied ‐ decoding of drugs at the end of week 12. Code broken at the end of treatment period. Double‐dummy design. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of N = 205 randomised, n = 7 were excluded, either because they had been given other neuroleptics or they revealed physical disease during the trial prior to breaking the randomisation code. A total of n = 198 were included in the analysis. |
Selective reporting (reporting bias) | Unclear risk | No means, SD or P values reported for scale data. |
Other bias | Unclear risk | Funding: not stated ‐ study drugs were supplied by Daiichi Seiyaku Co, Ltd, Tokyo, Japan. Raters: not stated to be independent of treatment. |