Fluphenazine depot 1973.

Study characteristics
Methods	Randomisation: randomly allocated by research assistant. Allocation: a part from the research assistant no one knew who was on drug or placebo until the data were analysed. Blinding: double‐blind, sesame oil injections, unmarked ampoules. Blinding was tested at the end of the trial and it worked. Duration: 9 months. Design: parallel. Location: two centres. Setting: outpatient.
Participants	Diagnosis: chronic schizophrenia (Present State Examination), chronicity defined by at least 2 admissions or 1 admission lasting longer than 6 months, 71 schizophrenic psychosis with delusions or auditory hallucinations, six non affective delusional psychoses, three catatonic schizophrenia. N = 81. Gender: 52 men, 29 women. Age: mean 43.4 years. History: duration stable‐ at least 8 weeks, duration ill‐ n.i., number of previous hospitalisations‐ 24 had ≤3 and 57 had ≥4), age at onset‐ n.i., severity of illness‐ n.i., baseline antipsychotic dose‐ 86% fluphenazine depot 25 mg/month, no additional antipsychotic medication.
Interventions	1. Drug ‐ Fixed/flexible dose: allowed dose range: 25 mg/month ‐ no upper limit. Mean dose: 26.4 mg/month. N = 41. 2. Placebo: duration of taper: n.i.. N = 40. Rescue medication: antidepressants, antiparkinson medication
Outcomes	Examined Relapse: deterioration of condition to a degree that participant had to be taken out of the trial to ensure that active medication was prescribed, prescription of oral phenothiazines. Leaving the study early. Service use: number of participants hospitalised. Number of participants employed. Death. Violent/aggressive behaviour. Adverse effects: use of antiparkinson medication. Unable to use/Not included Mental state: Present State Examination (no data/no predefined outcome of interest). Social functioning: Social Performance Schedule, Events Schedule of Bron and Birley (no usable data) Suicidal ideation (no usable data, only reported as referred by the patients´ informants to the study rater).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly allocated by research assistant.
Allocation concealment (selection bias)	Low risk	Apart from the research assistant no one knew who was on drug or placebo until the data were analysed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, sesame oil injections, unmarked ampoules. Blinding was tested at the end of the trial and it worked.
Blinding (performance bias and detection bias) Subjective outcomes	Low risk	Double‐blind, sesame oil injections, unmarked ampoules. Blinding was tested at the end of the trial and it worked.
Blinding (performance bias and detection bias) Objective outcomes	Low risk	Double‐blind, sesame oil injections, unmarked ampoules. Blinding was tested at the end of the trial and it worked.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Overall, 43% of the participants left the study early (no complete ITT for some outcomes).
Selective reporting (reporting bias)	Low risk	No evidence for selected reporting.
Other bias	Low risk	No evidence of other bias