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. 2020 Aug 11;2020(8):CD008016. doi: 10.1002/14651858.CD008016.pub3

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.
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.
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).
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.