Cole 1964.
Methods | Allocation: randomised (individually numbered containers of medicines). Blindness: double‐blind. Duration: 6 weeks. Setting: multi‐centre. | |
Participants | Diagnosis:DSM schizophrenia (50% first episode). N=463. Age: 16‐45 years, mean ˜ 28 years. Sex: male and female (proportions not given). History: acute, 60% first hospitalisation, no significant hospitalisation 12 months prior to current admission. | |
Interventions | 1. Chlorpromazine: dose range 200‐1200 mg/day. N=112.
2. Fluphenazine: dose range 2‐16 mg/day. N=115.
3. Thioridazine: dose range 200‐1600 mg/day. n=111.
4. Placebo. 2‐16 doses. N=125. Plus antiparkinsonian medication as needed for extrapyramidal side effects. |
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Outcomes | Leaving the study early.
Adverse effects. Unable to use. Global state: Global rating of severity of illness, improved/not improved ‐no usable data. Inpatient Multidimensional Psychiatric Scale (IMPS) ‐ no usable data. Ward Behaviour Rating Scale (WBRS) ‐ no usable data. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised ‐ no further details. |
Allocation concealment (selection bias) | Low risk | Individually numbered containers of medicines. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, untested. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study attrition reported (not addressed in analysis). |
Selective reporting (reporting bias) | Unclear risk | No details. |
Other bias | Unclear risk | No details. |