Pharmacological Intervention Project (Fluoxetine) (FIDAA)
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|ClinicalTrials.gov Identifier: NCT00027378|
Recruitment Status : Completed
First Posted : December 5, 2001
Results First Posted : July 18, 2013
Last Update Posted : July 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Depression||Drug: fluoxetine (Prozac) Drug: Placebo plus Treatment As Usual||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Pharmacological Intervention Project (Fluoxetine)|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2008|
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027378
|United States, Pennsylvania|
|Western Psychiatric Institute and Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Jack Cornelius, M.D.||Western Psychiatric Institute and Clinic Pittsburgh|