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

Fluphenazine 1980.

Study characteristics
Methods Randomisation: random 2:1, no further details.
Allocation: procedure not described.
Blinding: double‐blind, no further details.
Duration: 15 weeks.
Design: parallel.
Location: four hospitals.
Setting: outpatient.
Participants Diagnosis: schizophrenia (DSM‐II).
N = 67.
Gender: 34 men, 33 women.
Age: mean 31.7 years.
History: duration stable‐ continuously and successfully treated for one year, duration ill‐ n.i., number of previous hospitalisations‐ n.i., age at onset‐ n.i., severity of illness‐ n.i., baseline antipsychotic dose‐ oral fluphenazine mean 24.4 mg/day, depot fluphenazine 30.9 mg/3 weeks.
Interventions 1. Drug: oral fluphenazine (n = 6) or depot fluphenazine (n = 11). Fixed/flexible dose: unclear. Allowed dose range: unclear. Mean dose: unclear. N = 17.
2. Placebo: duration of taper: 0 days. N = 50.
Rescue medication: n.i., but antipsychotics were probably not allowed.
Outcomes Examined
Relapse: rehospitalisation or deterioration in clinical condition which could not be managed within protocol limits (e.g. increased psychological support or adjustment of dosage).
Adverse effects: tardive dyskinesia (AIMS).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random 2:1, no further details.
Allocation concealment (selection bias) Unclear risk Procedure not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind, no further details.
Blinding (performance bias and detection bias)
Subjective outcomes Unclear risk Double‐blind, no further details.
Blinding (performance bias and detection bias)
Objective outcomes Low risk Double‐blind, no further details.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk It is unclear whether there were participants who left the study early.
Selective reporting (reporting bias) Low risk No evidence for selective reporting.
Other bias Low risk No clear evidence for other bias.