Moak 2003.
Methods | Randomized, placebo‐controlled trial | |
Participants | 82 depressed people with alcohol dependence (50 men and 32 women; age (mean ± SD): sertraline = 41 ± 11 years; placebo = 42 ± 10 years) Inclusion criteria:
Exclusion criteria:
Participants with bipolar disorder were excluded. |
|
Interventions | Drugs:
Psychotherapy:
Scheduled duration of treatment: 12 weeks Site: Alcohol Research Center, Center for Drug and Alcohol Programs, Charleston, SC, USA Setting: outpatients Route of administration: orally Starting dose: 50 mg/day Pattern of dose reduction: titrated back down 50 mg over 7‐day period |
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Outcomes | Depression:
Alcohol dependence:
Dropout Adverse effects |
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Notes |
Baseline characteristics of participants Depression:
Alcohol dependence:
Other psychiatric comorbidity: participants with other mental disorders were excluded. Other substance use disorders: participants with substance use disorders were excluded. Other characteristics of study Other pharmacological treatment offered: other pharmacological treatments were not allowed. Funding source: National Institute on Alcohol Abuse and Alcoholism (grant AA10476). Pfizer supplied study drug and matched placebo. Declarations of interest: information not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Urn randomization used. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, placebo‐controlled medication design applied. Medications dispensed in identically tablets. No further details provided on blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) objective | Low risk | No information provided on blinding of assessors. |
Blinding of outcome assessment (detection bias) subjective | Unclear risk | No information provided on blinding of assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis used. |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported. |