Kranzler 2006 arm B.
Methods | Randomized, double‐blind, placebo‐controlled trial | |
Participants | 139 depressed people with alcohol dependence (86 men and 53 women; age (mean ± SD): placebo = 42.9 ± 9.2 years; sertraline = 41.8 ± 9.4 years) Inclusion criteria:
Exclusion criteria:
Participants with bipolar disorder were excluded. |
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Interventions | Drugs:
Psychotherapy: At each study visit, participants received supportive therapy delivered according to a manual developed specifically for study consisting of:
Scheduled duration of treatment: up to 10 weeks Sites: 13 investigative sites in the USA Setting: outpatients Route of administration: orally Starting dose: 50 mg/day Pattern of dose reduction:
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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: study supported by Pfizer Pharmaceuticals. Manuscript preparation supported by NIH grant K24 AA13736. Declarations of interest: information not available Other information In the original study, 328 participants were divided into the 2 groups on whether initially elevated HRSD score declined with cessation of heavy drinking:
In the present meta‐analysis, participants were divided into 2 substudies:
Both the substudies (Kranzler 2006 arm A; Kranzler 2006 arm B) were included in the 'Effects of interventions: Antidepressants versus placebo' comparison. Unfortunately, the original study did not report the adverse events for the single substudies. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization schedule reported. |
Allocation concealment (selection bias) | Unclear risk | The method of concealment was not described. Despite random assignment, participants who received placebo were older, reported more drinks per week during the pretreatment period, and had higher CGI depression scores at baseline. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided. |
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 | All analyses used an intention‐to‐treat approach. Weekly comparisons including only participants for whom data were available from that visit, whereas end of study analyses used last observation carried forward analysis. |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported. However, some of them were reported only as a % reduction (e.g. BDI score). |