Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027378
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-12-04
Brief Title:
Pharmacological Intervention Project Fluoxetine
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pharmacological Intervention Project Fluoxetine
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIDAA
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 AUDMDD
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AA-13370 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AA013370 |
| R01AA015173 | NIH | None | None |
| R01AA013370 | NIH | None | None |