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

Altintoprak 2008.

Methods Double‐blind, randomized, comparative trial
Participants 44 depressed people with alcohol dependence (number of men and women: information not available; mean age: information not available). Sociodemographic characteristics available only for 36 participants (20 mirtazapine, 16 amitriptyline).
Inclusion criteria:

  • aged 18‐65 years

  • current DSM‐IV diagnoses of alcohol dependence and depressive disorder

  • HDRS score ≥ 14 after detoxification


Exclusion criteria:

  • serious physical illness

  • for women, lack of protection against pregnancy, pregnancy, or breastfeeding

  • other major psychiatric disorder on the DSM‐IV axis‐I other than depressive disorder

  • history of a psychiatric problem other than depressive disorder

  • organic brain diseases

  • history of hypersensitivity to mirtazapine or amitriptyline

  • other drug dependence and abuse, excluding nicotine and caffeine

  • consumption of alcohol during study


Participants with bipolar disorder were excluded.
Interventions Drugs:

  • mirtazapine (30‐60 mg/day; 24 participants)

  • amitriptyline (100‐150 mg/day; 20 participants)


Psychotherapy: information not available.
Scheduled duration of treatment: 8 weeks.
Site: Ege University School of Medicine Hospital, Specialized Addiction Unit, Izmir, Turkey
Setting: inpatient
Route of administration: orally
Starting dose:

  • mirtazapine: 15 mg/day (increased to 30 mg/day at the third day; at end of first week, dose was increased to 45‐60 mg/day if severity of symptoms persisted)

  • amitriptyline 50 mg/day (increased to 100 mg/day at the third day; at end of first week, dose was increased to 125‐150 mg/day if severity of symptoms persisted)


Pattern of dose reduction: information not available
Outcomes Depression:

  • final HRSD score


Alcohol dependence: data not available
Alcohol craving:

  • final score in a questionnaire prepared by authors


Dropouts: data not available
Adverse effects:

  • evaluated using the UKU scale


Bodyweight:

  • final value


Anxiety:

  • final STAI score
Notes Baseline characteristics of participants
Depression:

  • primary depression (rate of participants): 34.1%

  • duration: information not available

  • HRSD score (mean ± SD): mirtazapine = 24.0 ± 4.4; amitriptyline = 23.7 ± 4.8


Alcohol dependence:

  • MAST score (mean ± SD): 38.9 ± 6.1

  • duration (mean ± SD): 12.1 ± 3.9 years

  • being actively drinking: people who consumed alcohol during study were excluded from study.

  • length of abstinence: 2 weeks


Anxiety:

  • STAI score (mean ± SD): mirtazapine = 51.8 ± 3.9; amitriptyline = 53.4 ± 4.5.


Global assessment: information not available.
Weight (mean ± SD):

  • mirtazapine = 75.9 ± 16.2 kg; amitriptyline = 71.4 ± 10.9 kg


Other psychiatric comorbidity: participants with other psychiatric disorders were excluded.
Other substance use disorders: participants with other substance use disorders were excluded.
Other characteristics of study
Other pharmacological treatment: no other pharmacological treatment was allowed.
Funding sources: not available.
Declaration of interest: not available.
Other information
After their inclusion in study, participants were admitted at a specialized department for alcohol detoxification on an inpatient basis. Alcohol consumption was prohibited during hospitalization and people who consumed alcohol during study were excluded from study. At end of alcohol detoxification treatment (approximately 10‐14 days), people were included in study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random allocation stated. No further details provided.
Allocation concealment (selection bias) Unclear risk Method of concealment not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind stated. Medication and placebo prepared to appear identical ("Both the clinicians and patients were blind to the treatment. Drugs were given in identical‐looking opaque capsules").
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 High risk Intention‐to‐treat approach not used ("Dropouts were not included in the analysis due to missing data"). People who consumed alcohol during study were excluded by study.
Selective reporting (reporting bias) High risk People who consumed alcohol during study were excluded by study.