Lieberman 2003 (CPZ).
Methods | Allocation: randomised. Blindness: double. Duration: 52 weeks. Setting: not stated. | |
Participants | Diagnosis: people with schizophrenia (DSM IV). N=160*. Age= 28.6 years. Sex: 77 F, 83 M. Setting: inpatients. History: naive first episode patients. | |
Interventions | 1. Clozapine + BZ placebo: dose mean 292 mg/day, max 400 mg/day. N=80. 2. Chlorpromazine + BZ: dose mean 319 mg/day, max 600 mg/day; 2 mg/bid (BZ). N=80. | |
Outcomes | Leaving the study early. Unable to use ‐ Remission 52 weeks. Mental state: BPRS, SANS (no usable data). Global state: CGI, GAF (no usable data). Adverse effects: COSTART, SAESS (no usable data). Physiological measurements: ECG, WBC, serum glucose (no usable data). |
|
Notes | 164 patients were randomised. Four of them withdrew before the first administration of medication, thus they report as randomised 160 patients. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomised ‐ no details |
Allocation concealment? | Unclear risk | No details |
Blinding? All outcomes | Unclear risk | Double blind, untested |
Incomplete outcome data addressed? All outcomes | Low risk | Numbers reported but reasons for attrition not described |
Free of selective reporting? | Unclear risk | No details |
Free of other bias? | High risk | Funded by Novartis Pharmaceuticals |