Cornelius 1997.

Methods	Randomized, double‐blind, placebo‐controlled trial
Participants	51 depressed people with alcohol dependence (26 men and 25 women; age (mean ± SD) = 34.8 ± 10.2 years) Inclusion criteria: current DSM‐III‐R diagnoses of depression and alcohol dependence Exclusion criteria: diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, or non‐alcohol substance dependence hyperthyroidism or hypothyroidism clinically significant medical diseases pregnancy mental retardation or cognitive impairment use of antipsychotic or antidepressant medication in the previous month Participants with bipolar disorder were excluded.
Interventions	Drugs: fluoxetine (20 mg/day; 25 participants) placebo (26 participants) Psychotherapy: weekly supportive psychotherapy sessions weekly meetings with an attending psychiatrist with expertise in treating people with dual‐disorder attendance at Alcoholics Anonymous was encouraged. Scheduled duration of treatment: 12 weeks Site: Western Psychiatric Institute and Clinic of the University of Pittsburgh, Pittsburgh, USA Setting: inpatients for first 2 weeks of abstinence, then outpatients Route of administration: orally Starting dose: 20 mg/day increased to 40 mg/day after 2 weeks if substantial residual depressive symptoms persisted Pattern of dose reduction: information not available
Outcomes	Depression: difference between baseline and final HRSD score difference between baseline and final BDI score Alcohol dependence: rate of abstinent days (obtained from cumulative number of drinking days) number of abstinent participants number of drinks per drinking day number of heavy drinking days per week (obtained from the cumulative number of heavy drinking days) time to first relapse (obtained from the number of weeks until first relapse) Global assessment: severity (difference between baseline and final GAS score) Dropouts: information not available Adverse effects: information not available
Notes	Baseline characteristics of participants Depression: primary depression: 100% duration: information not available after detoxification and washout, HRSD score (mean ± SD): fluoxetine = 19.2 ± 8.2; placebo = 17.9 ± 8.1 number of diagnostic criteria (mean ± SD): fluoxetine = 6.7 ± 1.1; placebo = 6.8 ± 1.1 current suicide ideation: fluoxetine = 92.0%; placebo = 88.5% Alcohol dependence: number of diagnostic criteria (mean ± SD): fluoxetine = 5.5 ± 1.6; placebo = 5.9 ± 1.8; range: 3.9‐7.7 duration: information not available being actively drinking: participants were actively drinking length of abstinence: 0 number of drinking days in past 90 days (mean ± SD): fluoxetine = 54.5 ± 29.2; placebo = 45.2 ± 28.9 number of days drinking to drunkenness in past 90 days (mean ± SD): fluoxetine = 40.1 ± 27.7; placebo = 32.0 ± 26.4 Other psychiatric comorbidity: participants with other mental disorders were excluded. Other substance‐use disorders: participants with substance‐use disorders were excluded. Abuse of other substances was not an exclusionary criterion, provided that alcohol was the main substance of abuse. Other characteristics of study Other pharmacological treatment: other pharmacological treatments were not allowed. Funding sources: work was supported by the National Institute on Alcohol Abuse and Alcoholism (grants AA09127 and AA10523), and by the Mental Health Clinical Research Center, Rockville, MD (grant MH30915). Declarations of interest: information not available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomization balanced for gender and race. It was not reported whether a computer‐generated list was used.
Allocation concealment (selection bias)	Unclear risk	Information insufficient to permit judgement. Method of concealment not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Medications were administered in identical opaque capsules. Substantial blood levels of fluoxetine were observed in more than 99% of participants assigned to fluoxetine. Not reported if blood analyses were made also to participants who received placebo.
Blinding of outcome assessment (detection bias) objective	Low risk	No information on the blinding of outcome assessors.
Blinding of outcome assessment (detection bias) subjective	Unclear risk	No information on the blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat analysis and last point carried forward analysis applied.
Selective reporting (reporting bias)	Unclear risk	Information insufficient to permit judgement.