Fluphenazine depot 1992.

Study characteristics
Methods	Randomisation: random, no further details. Allocation: procedure not described. Blinding: double‐blind, placebo was sesame oil of identical volume and identical in physical appearance. Duration: 12 months. Design: parallel. Location: single‐centre. Setting: inpatient, sponsored.
Participants	Diagnosis: chronic schizophrenia (Research Diagnostic Criteria), stable for at least 5 years (absence of clinical deterioration and/or an increase of neuroleptic medication, retrospectively and in addition prospectively for at least 12 months), all on fluphenazine decanoate. N = 24. Gender: n.i.. Age: mean 57.3 years. History: duration stable‐ retrospectively at least 5 years, prospectively for 12 months, mean 7 years, duration ill‐ mean 33.1 years, number of previous hospitalisations‐ n.i., but mean duration of hospitalisation 24.9 years (unclear whether current or life‐time total), age at onset‐ mean 24.3 years, severity of illness‐ mean BPRS total score 24.9, baseline antipsychotic dose‐ mean 41.9 mg fluphenazine/4 weeks, remission at baseline: yes (study defined).
Interventions	1. Drug: fluphenazine decanoate.Fixed dose: mean 50.4 mg/4 weeks. N = 12. 2. Placebo: duration of taper: 0 days, but all participants were on depot medication before the study. N = 12. Rescue medication: n.i., but probably not allowed.
Outcomes	Examined Relapse: at least 25% increase of BPRS total score and judgement of by nurse according to Psychotic Inpatient Profile. Unable to us /Not included Mental state: BPRS total, Psychotic Inpatient Profile (for both scales means for subgroups only / no predefined outcome of interest). Physiological measures: prolactin levels (no SD’s/no predefined outcome of interest).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random, 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, placebo was sesame oil of identical volume and identical in physical appearance,
Blinding (performance bias and detection bias) Subjective outcomes	Unclear risk	Double‐blind, placebo was sesame oil of identical volume and identical in physical appearance.
Blinding (performance bias and detection bias) Objective outcomes	Low risk	Double‐blind, placebo was sesame oil of identical volume and identical in physical appearance.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There is no statement on participants leaving the study early.
Selective reporting (reporting bias)	Low risk	No evidence for selective reporting.
Other bias	High risk	There was a baseline imbalance in terms of gender and in terms of baseline fluphenazine dose.