Pharmacological Intervention Project (Fluoxetine)

Official Title: “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 and major depression. 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 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(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • fluoxetine plus Treatment As Usual (TAU)
• Placebo Comparator: 2
  • placebo plus Treatment As Usual (TAU)

Primary Measures

• Alcohol use behaviors
  • Time Frame: 9 months
    Safety Issue?: No
• Depressive symptoms
  • Time Frame: 9 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: 20 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00027378

Study ID Number: NIAAACOR13370

ClinicalTrials.gov Identifier: NCT00027378

Health Authority: United States: Federal Government