Gillin 1997.

Methods	Randomised, double‐blind, multicentre, controlled, parallel group trial
Participants	Insomnia diagnosis criteria (method of diagnosis): 1 of the following subjective criteria for a sleep disturbance: difficulty in falling asleep on a nightly basis, waking up during the night, inability to fall asleep again after waking during the night on HAM‐D Other diagnoses: moderate to severe nonpsychotic MDD (DSM III‐R) on the basis of a structured clinical interview (minimal score of 18 on the first 17 items of HAM‐D‐17 Number of participants randomised: n = 44, but only 43 evaluable Nefazodone: n = 23 (1 not evaluable) Fluoxetine: n = 20 Age, mean (SD) years: Nefazodone: 35.3 (1.8) Fluoxetine: 36.7 (1.9) Gender (M/F): Nefazodone: 8/16 Fluoxetine: 6/14 Race/ethnicity: 68% white; 5% black; 6% Hispanic: 1% Asian Nefazodone: 15 white; 4 black; 5 Hispanic, 0 Asian Fluoxetine: 15 white; 1 black; 1 Hispanic; 1 Asian Country: University of California, San Diego, University of Pennsylvania, USA Setting: psychiatric outpatients, 4 sites Included: minimal score of 18 on the first 17 items of the HAM‐D‐17 at end of the baseline phase of no medication. And 1 of the following subjective criteria for a sleep disturbance: difficulty in falling asleep on a nightly basis, waking up during the night, inability to fall asleep again after waking during the night Excluded: shift workers, primary sleep disorders independent of affective disturbance, current general medical conditions or history of psychoactive substance disorder use within 12 months prior to study entry. DSM III R axis disorders ‐ organic mental syndromes and disorders, bipolar disorder ‐ depressed and schizophrenia, delusional disorder or psychotic disorders. Pregnant, lactating or sexually active women not using an approved method of contraception
Interventions	Intervention: nefazodone (days 1‐7, 200 mg/day (100 mg twice daily); days 8‐56, 400 mg/day (200 mg twice daily) If clinically indicated the dose could be increased to 500 mg/day on day 29 Comparator: fluoxetine days 20 mg/day for 56 days If clinically indicated, the dose could be increased to 40 mg/day on day 29.
Outcomes	Primary outcome Sleep disturbance assessments ‐ items on HAM‐D and 4 items on clinician and self‐rated IDS (end point defined at last observation at or before week 8) Secondary outcomes Sleep consolidation Tolerability/adverse events Sleep architecture
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Parallel design; stated double‐blind double‐dummy dosing scheme
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details given
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details given
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No details given
Selective reporting (reporting bias)	Unclear risk	ITT analysis (Pg 187)
Other bias	Unclear risk	Declaration included, but meaning unclear