Pharmacological Intervention Project (Fluoxetine)
Condition: Alcoholism; Depression
MeSH terms: Alcoholism; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment
      of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals
      will receive treatment for 12 weeks with a followup phase lasting 9 months.
    

Detailed description: 
      Recently, the first large-scale double-blind, placebo-controlled study of a selective
      serotonin reuptake inhibitor (SSRI) antidepressant in depressed adolescents was completed
      (Emslie et al., 1997) That study demonstrated efficacy for fluoxetine in non-AUD adolescents
      with major depressive disorder (MDD). Our own research group recently completed a first
      double-blind, placebo-controlled study of fluoxetine in adults with comorbid MDD and alcohol
      dependence (Cornelius et al., 1997). That study demonstrated efficacy for fluoxetine in
      decreasing both the depressive symptoms and the alcohol use of adult depressed alcoholics.
      Our own research group also recently completed a pilot study involving open label fluoxetine
      in adolescents with comorbid AUD and MDD. That pilot study demonstrated within-group efficacy
      for fluoxetine for decreasing both the drinking and the depressive symptoms of that
      population, and suggested that fluoxetine is a safe medication in this population (Cornelius,
      et al., In Press). However, to date, no double-blind, placebo-controlled study of any
      selective serotonin re-uptake inhibitors (SSRI) medication has been conducted in adolescents
      with a comorbid AUD and MDD. In this proposed study, a first large scale prospective
      double-blind, placebo-controlled study will be undertaken involving the SSRI medication
      fluoxetine versus placebo in the treatment of adolescents with an alcohol use disorder and
      major depression (AUD/MDD).

      The goals of the study include the following: 1) to compare the efficacy of the SSRI
      medication fluoxetine plus Treatment As Usual (TAU) to placebo plus TAU for the alcohol use
      and the depressive symptoms of an adolescent sample (ages 15 to 18) of subjects with comorbid
      diagnoses of an AUD and MDD; 2) to assess specific predictors of medication response in that
      study; and to perform a preliminary evaluation of the longer-term efficacy of fluoxetine in
      these patients, in a 9-month naturalistic follow-up period beyond the 3 month acute phase
      study. We hypothesize that fluoxetine plus TAU will demonstrate efficacy for decreasing both
      the drinking and the depressive symptoms of this population.
    

Intervention name(s): fluoxetine (Prozac); Placebo plus Treatment As Usual
Intervention type(s): Drug; Drug
Intervention description(s): fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up; placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: fluoxetine,; adolescents,; alcohol dependence,; major depression; Alcoholism