Mulholland 1997.
Methods | Allocation: randomised, computer generated numbers. Blindness: double, identical placebo capsules. Duration: 8 weeks. | |
Participants | Diagnosis: schizophrenia (DSM‐III‐R), depression (>= 3 on BPRS depression and >= 15 on BDI). N=26. Sex: female 10, male 16. Age: mean 38 years. History: duration ill ˜ 15 years. Setting: out‐patients. Phase: stable, no admission to hospital in previous 6 months. Medication History: people with significant EPS excluded. All on neuroleptic medication. 16 of the 26 were on anticholinergics. | |
Interventions | 1. Sertraline: dose 50 mg/day 4 weeks, 100 mg/day next 4 weeks if tolerated. N=13. 2. Placebo. N=13. Both groups: neuroleptic and anticholinergic. | |
Outcomes | Mental State: HAM(D), BPRS.
Leaving the study early.
Clinical recovery: CGI minimal or better improvement. Unable to use ‐ Mental state: BDI (HAM(D) used in preference). |
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Notes | ITT analysis performed. Unpublished results provided by authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |