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

Fluphenazine depot 1979a.

Study characteristics
Methods Randomisation: no details (just reported as a "randomised study”).
Allocation: procedure not described.
Blinding: "double‐blind” ("patients and authors were not aware of the allocated treatment”).
Duration: 9 months.
Design: randomised, parallel (enriched design: patients, who responded to fluphenazine long‐acting treatment (25 mg or 50 mg/month) for at least six to 12 months before study entry, were randomised to continue that treatment or to placebo). Ten out of 20 patients had been previously recruited in a study comparing fluphenazine with trifluorazine.
Location: no clear details.
Setting: outpatients.
Participants Diagnosis: chronic schizophrenia with an acute episode within 6 to 12 months before study entry (no details about diagnostic criteria).
N = 20.
Gender: all men.
Age: 19 to 32 years.
History: duration stable at least six months, duration ill‐ some were first episode patients, some were patients with recurrence, number of previous hospitalisations‐ no data, age at onset‐ no data, severity of illness‐ fluphenazine group had a mean BPRS baseline score of 24.56 (SD 3.56); placebo group had a mean BPRS baseline score of 21.71, baseline antipsychotic dose (25 mg or 50 mg/month).
Interventions 1. Drug: fluphenazine depot. Fixed dose: 25 mg or 50 mg/month (long‐acting formulation). Mean dose: n.i.. N = 10 randomised (but data available only for 9 patients who completed the study).
2. Placebo: duration of taper (days): n.i.. N = 10 randomised (but data available only for 7 patients who completed the study).
Rescue medication: antiparkinson medication at study entry (and then progressively tapered off, without a prespecified schedule).
Outcomes Examined
Relapse: defined as worsening of clinical status needing an adjunctive new antipsychotic treatment.
Leaving the study early.
Global state: number of participants improved.
Unable to use/Not included
Mental state: BPRS (no prespecified outcome of interest).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details (just reported as a "randomised study”).
Allocation concealment (selection bias) Unclear risk Procedure not described.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind ("patients and authors were not aware of the allocated treatment").
Blinding (performance bias and detection bias)
Subjective outcomes Unclear risk Double‐blind ("patients and authors were not aware of the allocated treatment”).
Blinding (performance bias and detection bias)
Objective outcomes Low risk Double‐blind ("patients and authors were not aware of the allocated treatment”).
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 25% of the participants dropped out, all due to relapse. This may still be acceptable.
Selective reporting (reporting bias) Low risk No evidence for selective reporting.
Other bias Low risk No clear other bias.