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

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:
  • current DSM‐III‐R diagnoses of depression or dysthymic disorder and alcohol dependence or abuse

  • HRSD ≥ 17, both at screening and at the end of 1 week of single‐blind placebo

  • minimum of 40 standard drinks during month before study entry


Exclusion criteria:
  • any current psychoactive substance dependence other than nicotine

  • psychoactive substance abuse in month before study entry other than marijuana

  • current panic disorder or post‐traumatic stress disorder

  • lifetime history of bipolar affective or psychotic disorder

  • evidence of treatment‐resistant depression

  • significant current suicidal ideation or plan, homicidal ideation, unstable medical illness, or history of a seizure disorder


Participants with bipolar disorder were excluded.
Interventions Drugs:
  • sertraline (up to 200 mg/day; 38 participants)

  • placebo (44 participants)


Psychotherapy:
  • weekly individual CBT according to Project MATCH guidelines


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
Outcomes Depression:
  • final HRSD score

  • final BDI score

  • response (calculated from significant depression)


Alcohol dependence:
  • rate of abstinent days

  • number of drinks per drinking days

  • number of heavy drinkers (calculated from a figure on % without relapse)


Dropout
Adverse effects
Notes Baseline characteristics of participants
Depression:
  • primary depression (rate of participants): 85.4%

  • duration: information not available

  • HRSD score (mean ± SD): sertraline = 19.4 ± 2.6; placebo = 18.8 ± 2.4


Alcohol dependence:
  • number of drinks per drinking days (mean ± SD): sertraline = 11.3 ± 5.2; placebo = 10.5 ± 4.5

  • duration (mean ± SD): sertraline = 10.9 ± 8.0 years; placebo = 12.0 ± 8.6 years

  • being actively drinking: participants had to have drunk a minimum of 40 standard drinks during the month before

  • length of abstinence: not available


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
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.