Penfluridol 1987.
Study characteristics | ||
Methods | Randomisation: n.i., but double‐blind study. Allocation: procedure not described. Blinding: double‐blind, identical capsules. Duration: 12 weeks. Design: parallel. Location: single‐centre. Setting: unclear. | |
Participants | Diagnosis: chronic schizophrenia (DSM‐III), all on maintenance medication for control of continuous symptoms, all stable for at least 6 months. N = 30. Gender: 16 men, 12 women. Age: mean 36.0 years. History: duration stable‐ at least 6 months, duration ill‐ mean 11.1 years, number of previous hospitalisations‐ n.i., age at onset‐ 24.9 years, severity of illness‐ n.i., baseline antipsychotic dose‐ mean 297.5 mg/day chlorpromazine equivalent. |
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Interventions | 1. Drug: penfluridol. Fixed dose of 55 mg/week. N = 15. 2. Placebo: duration of taper: 0 days. N = 15. Rescue medication: antiparkinson medication and haloperidol, but this was considered to be a relapse. |
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Outcomes |
Examined Relapse (need of additional haloperidol medication). Leaving the study early. Unable to use/Not included Mental state (Scale for the Assessment of Positive Symptoms and Negative Symptoms ‐ no data /no predefined outcome of interest). Adverse effects: extrapyramidal side‐effects (Simpson Angus Scale (SAS) ‐ no data / continuous side‐effect results were not among the prespecified outcomes). Physiological measures: mean body weight, pulse rate, blood pressure, laboratory (all no data/no prespecified outcomes of interest). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | N.i., but double‐blind study. |
Allocation concealment (selection bias) | Unclear risk | Procedure not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double, identical capsules. |
Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double, identical capsules. |
Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double, identical capsules. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only study completers were used in the final analysis, but as there were only two dropouts (one in each group) this was not necessarily a problem. |
Selective reporting (reporting bias) | Low risk | Rating scale results were not reported, but these were not of interest for the review. |
Other bias | Low risk | No clear evidence for other bias. |