Pharmacological Intervention Project (Fluoxetine)

Last updated: June 17, 2013
Sponsor: University of Pittsburgh
Overall Status: Completed

Phase

2

Condition

Depression

Alcohol Use Disorder

Alcohol Dependence

Treatment

N/A

Clinical Study ID

NCT00027378
NIAAACOR13370
AA-13370
R01AA015173
R01AA013370
  • Ages 15-20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets criteria for alcohol use disorder and major depressive disorder.

Exclusion

Exclusion Criteria:

  • Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.

  • Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, andthose with significant liver disease.

  • Receiving antipsychotic or antidepressant medication in the month prior to enteringthe study.

  • Use of any illicit substance abuse or dependence other than cannabis abuse (andalcohol abuse).

  • History of intravenous drug use.

  • Pregnancy, inability or unwillingness to use contraceptive methods.

  • Inability to read or understand study forms

  • Less than 15 years of age or over 18 years of age will be excluded.

Study Design

Total Participants: 50
Study Start date:
July 01, 2001
Estimated Completion Date:
June 30, 2008

Study 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.

Connect with a study center

  • Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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