Pettinati 2001a.
Methods | Randomized, double‐blind, placebo‐controlled trial | |
Participants | 29 depressed people with alcohol dependence (number of men and women: data not available; mean age: data not available) Inclusion criteria:
Exclusion criteria:
Participants with bipolar disorder were excluded. |
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Interventions | Drugs:
Psychotherapy: weekly individual cognitive‐behavioural therapy Scheduled duration of treatment: 14 weeks Sites: University of Pennsylvania and the Carrier Foundation, USA Setting: outpatients Starting dose: 50 mg/day Pattern of dose reduction: tapering during the last 2 weeks of treatment |
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Outcomes | Depression:
Alcohol dependence:
Dropouts: information not available Adverse effects: information not available |
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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 (R01‐AA09544 and KO2‐AA00239) and by Veteran Affairs Medical Center. Pfizer Inc. provided sertraline and matching placebo. Declarations of interest: information not available Other information In the original study participants were divided into 2 groups:
Participants with lifetime depression were then divided into 2 subgroups:
In the meta‐analysis, we included only participants with current depression. Unfortunately, dropouts and adverse events were not provided for each subgroup. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation referred to 1 randomization schedule for both sites. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind stated and medications prepared to appear identical. No specific reference made to blinding of participants and personnel. |
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 used. |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported. |