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Pharmacological Intervention Project (Fluoxetine) (FIDAA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00027378
First received: December 4, 2001
Last updated: June 17, 2013
Last verified: June 2013

December 4, 2001
June 17, 2013
July 2001
June 2007   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
    Alcohol use behaviors measured by drinks per week.
  • Depressive Symptoms [ Time Frame: Average score as measured by participant's report on the Beck Depression Inventory (BDI). ] [ Designated as safety issue: No ]
    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).
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Complete list of historical versions of study NCT00027378 on ClinicalTrials.gov Archive Site
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Pharmacological Intervention Project (Fluoxetine)
Pharmacological Intervention Project (Fluoxetine)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alcoholism
  • Depression
  • Drug: fluoxetine (Prozac)
    fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up
  • Drug: Placebo plus Treatment As Usual
    placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up
  • Experimental: 1
    fluoxetine plus Treatment As Usual (TAU)
    Intervention: Drug: fluoxetine (Prozac)
  • Placebo Comparator: 2
    placebo plus Treatment As Usual (TAU)
    Intervention: Drug: Placebo plus Treatment As Usual
Cornelius JR, Bukstein OG, Wood DS, Kirisci L, Douaihy A, Clark DB. Double-blind placebo-controlled trial of fluoxetine in adolescents with comorbid major depression and an alcohol use disorder. Addict Behav. 2009 Oct;34(10):905-9. Epub 2009 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2007   (final data collection date for primary outcome measure)

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.
Both
15 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027378
NIAAACOR13370, R01AA015173, R01AA013370, AA-13370
No
Jack Cornelius, University of Pittsburgh
University of Pittsburgh
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Jack Cornelius, M.D. Western Psychiatric Institute and Clinic Pittsburgh
University of Pittsburgh
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP