Pharmacological Intervention Project (Fluoxetine) (FIDAA)

June 17, 2013 updated by: Jack Cornelius, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.
  • Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and those with significant liver disease.
  • Receiving antipsychotic or antidepressant medication in the month prior to entering the study.
  • Use of any illicit substance abuse or dependence other than cannabis abuse (and alcohol 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
fluoxetine plus Treatment As Usual (TAU)
Drug: fluoxetine (Prozac)
fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up
Placebo Comparator: 2
placebo plus Treatment As Usual (TAU)
Drug: Placebo plus Treatment As Usual
placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Behaviors
Time Frame: Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.
Alcohol use behaviors measured by drinks per week.
Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.
Depressive Symptoms
Time Frame: Average score as measured by participant's report on the Beck Depression Inventory (BDI).
Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).
Average score as measured by participant's report on the Beck Depression Inventory (BDI).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jack Cornelius, M.D., Western Psychiatric Institute and Clinic Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 4, 2001

First Submitted That Met QC Criteria

December 4, 2001

First Posted (Estimate)

December 5, 2001

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAACOR13370
  • R01AA015173 (U.S. NIH Grant/Contract)
  • R01AA013370 (U.S. NIH Grant/Contract)
  • AA-13370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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