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

Cocchi 1997.

Methods Randomized comparative trial
Participants 122 depressed people with alcohol dependence (95 men and 27 women; mean age: 42 years)
Inclusion criteria:
  • DSM‐IV diagnosis F10‐24

  • ZUNG score > 49


Exclusion criteria: information not available
Participants with bipolar disorder: information not available
Interventions Drugs:
  • paroxetine (20 mg/day; 61 participants; 49 men and 12 women; age (mean ± SD) = 42.1 ± 11.5 years)

  • amitriptyline (25 mg/day; 61 participants; 46 men and 15 women; age (mean ± SD) = 42.2 ± 10.7 years)


Psychotherapy: information not available
Scheduled duration of treatment: 3‐4 weeks
Site: Alcohol Unit, casa di Cura Villa Silvia per malattie nervose e mentali, Senigallia, Italy
Setting: inpatients
Route of administration: orally
Starting dose: information not available
Pattern of dose reduction: information not available
Outcomes Depression
  • final ZUNG score

  • response (according to ZUNG)

  • remission (according to ZUNG)


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

  • duration: information not available

  • ZUNG score (mean ± SD): paroxetine = 68.8 ± 9.0; amitriptyline = 63.3 ± 6.0


Alcohol dependence: data not available
Other psychiatric comorbidity: information not available
Other substance use disorders: information not available
Other characteristics of study
Other pharmacological treatment: information not available
Funding sources: information not available
Declaration of interest: information not available
Other information
Data on response and remission were excluded because evaluated using a self‐administered scale.
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 High risk No information on the design (double‐blind or open trial), on the preparation and appearance of medications, and on blinding of participants and personnel.
Blinding of outcome assessment (detection bias) objective Low risk No information on study design (double‐blind or open trial).
Blinding of outcome assessment (detection bias) subjective High risk No information on study design (double‐blind or open trial).
Incomplete outcome data (attrition bias) 
 All outcomes High risk Methods applied to account for missing data. Intention‐to‐treat approach not reported. No high number of dropouts or unbalanced between groups.
Selective reporting (reporting bias) Unclear risk Information insufficient to permit judgement.