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. 2004 Jan 26;2004(1):CD003545. doi: 10.1002/14651858.CD003545.pub2

Clark 1975.

Methods Allocation: pre‐randomised list, blocks of 3, provided by drug company. 
 Blindness: double (identical capsules). 
 Design: 3 parallel groups, single centre. 
 Duration: 4 weeks. 
 Analysis: intention‐to‐treat performed only for some outcomes. 
 Country: USA.
Participants Diagnosis: schizophrenia, confirmed by research psychiatry. 
 N=42. 
 Age: range: 21‐57 years. 
 Sex: M 21, F 16. 
 Setting: hospital. 
 History: newly admitted chronic patients. 
 Excluded: < 2 years of illness; < 18 years of age; mental deficiency, epilepsy, organic brain disease, metabolic disorders, liver, renal or cardiac disease.
Interventions 1. Trifluoperazine: dose 10 mg/day initially, then increasing to maximum 50 mg/day (mean 36 mg). N=14. 
 2. Loxapine: dose 20 mg/day initially, then increased to maximum 100 mg/day, (mean 71mg). N=15. 
 3. Placebo: 2‐10 capsules. N=13.
Outcomes Leaving the study early. 
 Side effects: (total; EPS; insomnia; weight; EKG). 
 Global state: (CGI; use of additional sedation). 
 Laboratory tests.
Unable to use ‐ 
 Mental state: (BPRS ‐ no SD). 
 Efficacy: (analysis of covariance ‐ no usable data). 
 Behaviour: (NOSIE ‐ no usable data). 
 Physiological measures: (BP, pulse ‐ no data).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear