Fluphenazine 1982.

Study characteristics
Methods	Randomisation: random, no further details. Allocation: procedure not described. Blinding: double‐blind, all participants received both pills and injections (active or placebo) to maintain double‐blind conditions. Duration: 1 year. Design: parallel. Location: single‐centre. Setting: outpatient.
Participants	Diagnosis: first episode schizophrenia (clinical diagnosis), no evidence of drug abuse or important medical illnesses. When diagnoses were reassessed by Research Diagnostic Criteria, 19 had schizophrenia, 3 had unspecific schizophrenic psychoses, 4 had other psychiatric disorders, one mania with schizotypal features and one depression with schizotypal features. N = 28. Gender: 14 men, 14 women. Age: mean 21.9 years. History: duration stable‐ stable remission of at least 4 weeks, mean 16.9 weeks, duration ill‐ mean 17.6 weeks, number of previous hospitalisations‐ 0, age at onset‐ mean 21.5 years, severity of illness‐ n.i., baseline antipsychotic dose‐ n.i..
Interventions	1. Drug: oral fluphenazine ‐ Flexible dose. Allowed dose range: 5‐20 mg/day. Mean dose: n.i.. N = n.i.. 2. Drug: depot fluphenazine ‐ Flexible dose. Allowed dose range: 12.5 mg to 50 mg biweekly. Mean dose: n.i.. N = n.i.. 2. Placebo: duration of taper: 0 days. N = 17. Rescue medication: not indicated.
Outcomes	Examined Relapse: a substantial clinical deterioration with a potential for marked social impairment. Patients were considered dropouts only if they showed no signs of clinical deterioration at the time they left the study. Leaving the study early. Unable to use/Not included Social aspects of premorbid personality: Premorbid Asocial Adjustment Scale (data on placebo group only/no predefined outcome of interest).
Notes	The design was changed during the study in that only non‐compliant patients were randomised to depot fluphenazine or depot placebo, and the randomisation was changed to 2‐1‐1 (placebo, oral fluphenazine, depot fluphenazine).
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, all participants received both pills and injections (active or placebo) to maintain double‐blind conditions.
Blinding (performance bias and detection bias) Subjective outcomes	Unclear risk	Double‐blind, all participants received both pills and injections (active or placebo) to maintain double‐blind conditions.
Blinding (performance bias and detection bias) Objective outcomes	Low risk	Double‐blind, all participants received both pills and injections (active or placebo) to maintain double‐blind conditions.
Incomplete outcome data (attrition bias) All outcomes	High risk	20 out of 28 participants  left the study early, 10 for other reasons than relapse, which was the only outcome apart from leaving the study early. This may present a bias.
Selective reporting (reporting bias)	Low risk	No evidence for selective reporting.
Other bias	Unclear risk	The design was changed during the study in that only non‐compliant patients were randomised to depot fluphenazine or depot placebo, and the randomisation was changed to 2‐1‐1 (placebo, oral fluphenazine, depot fluphenazine). It is unclear whether this biased the results.