Serafetinides 1972.
Methods | Allocation: randomly assigned ‐ no further description.
Blinding: double, used 'identically appearing capsules'.
Duration: 12 weeks (preceded by 12 week dry‐out period). Design: parallel. Country: USA. |
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Participants | Diagnosis: schizophrenia (criteria not specified). History: > 2 yrs ill. N=57*. Sex: 25 M, 32 F. Age: range 21‐61 yrs. Setting: hospital. | |
Interventions | 1. Chlorpromazine: dose max. 1000 mg/day. N=14.
2. Placebo: dose max. 10 capsules/day. N=13.
3. Haloperidol: dose max. 15 mg/day. N=14.
4. Clopenthixol: dose max. 250 mg/day. N=15. Medication given in variable dose regimen' medication for EPS or insomnia as required. |
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Outcomes | Leaving study early.
Global improvement. CGI.
Adverse effects.
Liver function. Unable to use ‐ Global improvement: CGI (discrepancy with group totals). Mental state: BPRS, Venables‐O'Conner scale (no SD). Behaviour: NOSIE, OBRS (no SD). Psychological function: test battery (no data). |
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Notes | *One participant not accounted for. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly assigned" no further details reported. |
Allocation concealment (selection bias) | Unclear risk | No information reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "All medications were prepared in identically appearing capsules" no further details reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Four of the 57 subjects, three on CPZ, and one on PL,failed to complete the 12 weeks of study. The PL subject and one CPZ subject were terminated because of behavioural deterioration after 4 and 8 weeks respectively. The other two CPZ subjects developed intestinal obstruction secondary to massive fecal impactions and were terminated in the 7th week of study." |
Selective reporting (reporting bias) | High risk | No SDs were reported for the CGI, NOSIE and the OBPRS. No data was reported for the psychological function tests. |
Other bias | Low risk | Supported in part by a US Public Health Service Grant. |