Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacological Intervention Project (Fluoxetine) (FIDAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00027378
Recruitment Status : Completed
First Posted : December 5, 2001
Results First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 4, 2001
First Posted Date  ICMJE December 5, 2001
Results First Submitted Date  ICMJE February 8, 2012
Results First Posted Date  ICMJE July 18, 2013
Last Update Posted Date July 18, 2013
Study Start Date  ICMJE July 2001
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Intervention Project (Fluoxetine)
Official Title  ICMJE Pharmacological Intervention Project (Fluoxetine)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcoholism
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1016/j.addbeh.2009.03.008. Epub 2009 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
50
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
106
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00027378
Other Study ID Numbers  ICMJE NIAAACOR13370
R01AA015173 ( U.S. NIH Grant/Contract )
R01AA013370 ( U.S. NIH Grant/Contract )
AA-13370
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jack Cornelius, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Jack Cornelius, M.D. Western Psychiatric Institute and Clinic Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2013

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