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. 2018 Apr 24;2018(4):CD008581. doi: 10.1002/14651858.CD008581.pub2

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:
  • aged ≥ 18 years

  • DSM‐III‐R diagnoses of depression and alcohol dependence


Exclusion criteria:
  • current substance dependence other than alcohol or nicotine

  • serious or unstable physical illness

  • bipolar illness, dementia, or psychosis

  • need for other psychotropic medications


Participants with bipolar disorder were excluded.
Interventions Drugs:
  • sertraline (up to 200 mg/day; 12 participants)

  • placebo (17 participants)


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
Outcomes Depression:
  • final HRSD score

  • final BDI score


Alcohol dependence:
  • rate of abstinent days (obtained from the rate of drinking days)

  • number of abstinent participants

  • time to first relapse


Dropouts: information not available
Adverse effects: information not available
Notes Baseline characteristics of participants
Depression:
  • primary depression: information not available

  • severity: information not available

  • duration: information not available


Alcohol dependence:
  • severity: information not available

  • duration: information not available

  • being actively drinking: participants had to be actively drinking in the past 30 days, seeking treatment for alcohol problems


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:
  • never depressed (47 participants)

  • with lifetime depression (53 participants; 26 men and 27 women; age (mean ± SD): sertraline = 42.3 ± 9.3 years; placebo = 43.8 ± 10.9 years)


Participants with lifetime depression were then divided into 2 subgroups:
  • with current depression (29 participants)

  • with only lifetime diagnosis of depression (24 participants)


In the meta‐analysis, we included only participants with current depression. Unfortunately, dropouts and adverse events were not provided for each subgroup.
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.