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. 2003 Apr 22;2003(2):CD000440. doi: 10.1002/14651858.CD000440

Mesotten 1991.

Methods Allocation: randomised (no further description). 
 Blindness: double (identical medication). 
 Duration: 8 weeks (preceeded by one week washout). 
 Consent: not stated. 
 Setting: multicentre.
Participants Diagnosis: schizophrenia, other serious psychotic disorders (DSM‐III). 
 N=60. 
 Age: 20‐65 years, mean ˜ 40 years. 
 Sex: 37M, 23F. 
 History: hospitalised, mean duration of hospitalisation ˜ 5 years. 
 Exclusions: continuous neuroleptic treatment for > 5 years, other significant physical of psychological illness, depot neuroleptics within 4 weeks of trial, pregnant or nursing females or those of reproductive age without adequate contraception.
Interventions 1. Risperidone: 2‐20 mg/day, and initial dose of 2mg/day was adjusted as required days 1‐28, FD thereafter. N=28. 
 2. Haloperidol: 2‐20 mg/day, an initial dose of 2 mg/day was adjusted as required days 1‐28, FD thereafter. N=32.
Outcomes Global effect: CGI improved/not improved. 
 Adverse effects: use of EPS medication, other various observed effects. 
 Leaving the study early. 
 Acceptability of treatment.
Unable to use ‐ 
 Global effect: CGI score (no SD). 
 Mental state: BPRS (no SD). 
 Behaviour: NOISE (no SD). 
 Physiological monitoring: ECG, lab tests (insufficient data). 
 Adverse effects: ESRS (no SD).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear