Penfluridol 1974b.
| Study characteristics | ||
| Methods | Randomisation: divided into two comparable groups by an unbiased statistician. Allocation: procedure not explained. Blinding: double‐blind, identical capsules. Duration: 6 months. Design: parallel. Location: single‐centre. Setting: inpatient, sponsored. | |
| Participants | Diagnosis: chronic psychotic inpatients (clinical diagnosis), 13 schizophrenia, 1 dementia, 1 paranoia. N = 15. Gender: 6 men, 9 women. Age: median 54 years. History: duration stable‐ n.i., duration ill‐ mean 17.7 years, number of previous hospitalisations‐ n.i., but mean duration of hospitalisation 11.3 years, age at onset‐ mean 36.3 years, severity of illness‐ n.i., baseline antipsychotic dose‐ n.i.. |
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| Interventions | 1. Drug: penfluridol. Fixed/flexible dose: unclear, but different doses according to pretrial medication. Allowed dose range: unclear, but all participants received 40 mg/week. Mean dose: 40 mg/week. N = 7. 2. Placebo: duration of taper: 0 days. N = 8. Rescue medication: Dexetimide was given prophylactically to prevent extrapyramidal side effects. |
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| Outcomes |
Examined Relapse: need of additional antipsychotic medication. Leaving the study early. Unable to use/Not included Mental state: Zwanikken Scale (no mean, no SD / no predefined outcome of interest). Behaviour: Zwanikken Scale (no mean, no SD / no predefined outcome of interest). Adverse effects: interview (no data). |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Divided into two comparable groups by an unbiased statistician. |
| Allocation concealment (selection bias) | Unclear risk | Procedure not explained. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, identical capsules. |
| Blinding (performance bias and detection bias) Subjective outcomes | Unclear risk | Double‐blind, identical capsules. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Double‐blind, identical capsules. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant left the study early. |
| Selective reporting (reporting bias) | Low risk | No evidence for selective reporting. |
| Other bias | Low risk | No clear other bias. |