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

Pettinati 2010 arm A.

Methods Randomized, double‐blind, placebo‐controlled trial
Participants 79 depressed people with alcohol dependence (49 men and 30 women; age (mean ± SD): sertraline = 43.9 ± 11.5 years; placebo = 43.4 ± 8.9 years)
Inclusion criteria:

  • current DSM‐IV diagnoses of depression and alcohol dependence

  • HRSD score ≥ 10


Exclusion criteria:

  • substance dependence besides alcohol or nicotine dependence

  • bipolar‐affective disorder, schizophrenia, or other psychotic or organic mental disorders

  • regular use of antidepressants

  • requiring psychiatric medications other than an antidepressant

  • severe medical illness

  • pregnant or breastfeeding


Participants with bipolar disorder were excluded.
Interventions Drugs:

  • sertraline (200 mg/day; 40 participants)

  • placebo (39 participants)


Psychotherapy: weekly individual CBT
Scheduled duration of treatment: 14 weeks
Site: University of Pennsylvania Treatment Research Center, USA
Setting: outpatients
Route of administration: orally
Starting dose: 50 mg/day
Pattern of dose reduction:

  • in week 14, sertraline was reduced to 100 mg/day;

  • medications were completed by the last treatment day.
Outcomes Depression:

  • final HRSD score

  • remission


Alcohol dependence:

  • number of abstinent participants

  • number of heavy drinkers (calculated from the figure on the rates of subjects without a heavy drinking day)

  • time to relapse


Dropouts
Adverse effects
Notes Baseline characteristics of participants
Depression:

  • primary depression (rate of participants): 100%

  • duration: information not available

  • HRSD score (mean ± SD): sertraline = 23.4 ± 6.0; placebo = 22.9 ± 7.0


Alcohol dependence:

  • number of drinks per drinking days (mean ± SD): sertraline = 12.4 ± 5.6; placebo = 10.5 ± 5.9

  • duration (mean ± SD): sertraline = 21.7 ± 10.6 years; placebo = 19.3 ± 10.1 years

  • being actively drinking: participants had to consume a mean of ≥12 alcoholic drinks per week and on ≥ 40% of the 90 days before treatment

  • length of abstinence: 3 days


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 R01‐AA09544‐10). Pfizer Inc., USA, Pharmaceutical Group provided sertraline and matching placebo.
Declaration of interest: the authors declared the grants received.
Other information
In the original study participants were divided into 4 groups:

  • sertraline (40 participants)

  • naltrexone (49 participants)

  • sertraline plus naltrexone (42 participants)

  • double placebo (39 participants)


In the meta‐analysis, data were analyzed and included in 2 substudies:

Both the substudies (Pettinati 2010 arm A; Pettinati 2010 arm B) were included in the 'Effects of interventions: Antidepressants versus placebo' comparison.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Urn randomization reported.
Allocation concealment (selection bias) Low risk Urn randomization used to evenly distribute participants across groups using 4 pretreatment variables: gender, regular smoking, HRSD scores at time of randomization, and drinking frequency.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
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 Missing data were imputed using appropriate methods.
Selective reporting (reporting bias) Low risk All expected outcomes reported.