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.
- Meets criteria for alcohol use disorder and major depressive disorder.
- 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
- Use of any illicit substance abuse or dependence other than cannabis abuse (and
- 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.