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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
5R01AA013370-04
Application #
6768570
Study Section
Special Emphasis Panel (ZAA1-DD (01))
Program Officer
Mattson, Margaret
Project Start
2001-07-01
Project End
2006-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
4
Fiscal Year
2004
Total Cost
$409,003
Indirect Cost
Name
University of Pittsburgh
Department
Psychiatry
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Cornelius, J R; Chung, T A; Douaihy, A B et al. (2016) A Review of the Literature of Mirtazapine in Co-Occurring Depression and an Alcohol Use Disorder. J Addict Behav Ther Rehabil 5:
Cornelius, Jack R; Chung, Tammy; Douaihy, Antoine B et al. (2016) Mirtazapine in comorbid major depression and an alcohol use disorder: A double-blind placebo-controlled pilot trial. Psychiatry Res 242:326-330
Cornelius, Jack R; Kirisci, Levent; Reynolds, Maureen et al. (2015) Does the Transmissible Liability Index (TLI) assessed in late childhood predict suicidal symptoms at young adulthood? Am J Drug Alcohol Abuse 41:264-8
Cornelius, Jack; Kirisci, Levent; Reynolds, Maureen et al. (2014) Does stress mediate the development of substance use disorders among youth transitioning to young adulthood? Am J Drug Alcohol Abuse 40:225-9
Cornelius, Jack R; Haas, Gretchen L; Goldstein, Gerald et al. (2014) The ""S"" Allele of the Serotonin Transporter Is Not Associated with Major Depression in a Sample OF Veterans. Adv Genet Res 12:1-10
Cornelius, Jack R; Haas, Gretchen L; Goldstein, Gerald et al. (2014) The ""S"" Allele of the Serotonin Transporter Is Not Associated with Major Depression or Alcohol Use Disorders in a Veteran Sample. Int J Med Biol Front 20:103-111
Cornelius, Jack R (2013) Editorial Regarding the New DSM-5 Diagnosis of PTSD in Veterans and Non-veterans. J Depress Anxiety 2:139-141
Cornelius, Jack R; Douaihy, Antoine B; Clark, Duncan B et al. (2013) Mirtazapine in Comorbid Major Depression and Alcohol Use Disorder: A Long-Term Follow-Up Study. J Addict Behav Ther Rehabil 3:
Cornelius, Jack R; Aizenstein, Howard J; Chung, Tammy A et al. (2013) Paradoxical Decrease in Striatal Activation on an fMRI Reward Task Following Treatment in Youth with Co-morbid Cannabis Dependence/Major Depression. Adv Psychol Res 93:123-130
Cornelius, Jack R; Kirisci, Levent (2013) Assessing TLI as a Predictor of Treatment Seeking for SUD among Youth Transitioning to Young Adulthood. Adv Psychol Res 98:85-94

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