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

Cornelius 2016.

Methods Randomized, double‐blind, placebo‐controlled trial
Participants 14 depressed people with alcohol dependence (10 men and 4 women; mean age = 41.3 years)
Inclusion criteria:
  • aged 18‐55 years

  • current DSM‐IV diagnoses of depression and alcohol dependence

  • eligible for outpatient treatment


Exclusion criteria:
  • aged < 18 years or over 55 years

  • presence of psychotic symptoms or a diagnosis involving psychosis

  • receiving psychotropic medication in the prior month

  • current DSM diagnosis of dependence or abuse on substances other than alcohol, cannabis, nicotine, or caffeine

  • current significant medical or neurological condition

  • suicidal ideation in the last 3 months, or lifetime suicidal attempt

  • positive pregnancy test or breastfeeding

  • inability or unwillingness to use contraceptive methods

  • inability to read or understand study forms

  • pending incarceration

  • current participation in another research study


Participants with bipolar disorder: information not available
Interventions Drugs:
  • mirtazapine (30 mg/day; 7 participants; 4 men and 3 women)

  • placebo (7 participants; 6 men and 1 woman)


Psychotherapy:
  • brief MET at each assessment


Scheduled duration of treatment: 12 weeks
Site: University of Pittsburgh, Western Psychiatric Institute and Clinic, Pittsburgh, USA
Setting: outpatients
Route of administration: orally
Starting dose:
  • 15 mg/day for the first 2 weeks

  • then 30 mg/day for 12 weeks


Pattern of dose reduction: information not available
Outcomes Depression:
  • final BDI score

  • difference between baseline and final BDI score


Alcohol dependence:
  • number of drinking days per week

  • number of drinks per drinking days

  • number of drinks per week

  • number of heavy drinking days per week


Craving for alcohol:
  • final OCDS score

  • difference between baseline and final OCDS score


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

  • duration: information not available

  • BDI score (mean ± SD): mirtazapine = 27.6 ± 7.7; placebo = 26.1 ± 11.7


Alcohol dependence:
  • severity: information not available

  • duration: information not available

  • number of drinks per drinking day (mean ± SD): 6.6 ± 2.0

  • being actively drinking: participants were not abstinent


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: participants did not receive other pharmacological treatments.
Funding sources: study received grants from the National Institute on Alcohol Abuse and Alcoholism (R21 AA022123, R21 AA022863, R01 AA013370, R01 AA015173, K24 AA15320) and from the National Institute on Drug Abuse (R01 DA019142, P50 DA05605, K02 DA017822).
Declarations of interest: information not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about sequence generation process to permit judgement of low or high risk.
Allocation concealment (selection bias) Unclear risk Method of concealment not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Medications were identical in appearance (identical‐looking opaque capsules).
Blinding of outcome assessment (detection bias) objective Low risk Medications were identical in appearance (identical‐looking opaque capsules).
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 approach reported.
Selective reporting (reporting bias) Low risk No dropouts