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

Schiele 1961.

Methods Allocation: randomly assigned (held by the pharmacist). 
 Blindness: double (identical capsules, coded bottles). 
 Design: 4 parallel groups, single centre. 
 Duration: 16 weeks (in strict double‐blind conditions) + 22 weeks, no washout period. 
 Analysis: intention to treat. 
 Country: USA.
Participants Diagnosis: schizophrenia, no further details. 
 N=80. 
 Age: mean 40.6 years. 
 Sex: males. 
 Setting: hospital. 
 History: chronic (average hospitalisation 10 years). 
 Excluded: people > 55 years and organic factors. 
 Included: inadvertently 3 with lobotomies (2 in the thioridazine group and other in the chlorpromazine).
Interventions 1. Trifluoperazine: 10‐50 mg/day, maximum 35 mg, 12 received less than the maximum. N=20. 
 2. Thioridazine: 200‐1000 mg/day, maximum 958 mg, 3 received less than the maximum. N=20. 
 3. Chlorpromazine: 200‐1000 mg/day, maximum 894 mg/day, 3 received less than the maximum. N=20. 
 4. Placebo: 2‐10 capsules. 
 Occasional additional medication, phenobarbital and benzotropine methansulfonate.
Outcomes Global state: (Clinical Evaluation). 
 Side effects. 
 Leaving the study early. 
 Use of antiparkinson agents.
Unable to use ‐ 
 Behaviour: (Behaviour rating scale ‐ no SD). 
 Mental state: (MMPI ‐ only 43 patients took the tests).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate