Depressive Disorder, Major Clinical Trial
Official title:
Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People
Adolescents who are diagnosed with major depressive disorder are often also diagnosed with marijuana dependence. Fluoxetine is an antidepressant medication currently used to treat young people who are diagnosed with major depressive disorder. The purpose of this study is to determine the effectiveness of fluoxetine in treating adolescents and young adults diagnosed with both major depressive disorder and marijuana dependence.
Marijuana dependence is the most common illicit substance use disorder in the United States.
Its prevalence is highest among adolescents and young adults. Major depressive disorder is
one of the most common conditions seen in marijuana dependent individuals. Fluoxetine is an
antidepressant medication for treatment of major depression among adolescents and children.
The purpose of this study is to determine the effectiveness of fluoxetine in treating
adolescents and young people dually diagnosed with major depressive disorder and marijuana
dependence.
Participants in this 12-week trial will be randomly assigned to receive either fluoxetine or
placebo. Participants will initially be randomly assigned to receive either 10 mg of
fluoxetine or placebo. Medication will be given in the morning. If no side effects are
observed over the first two weeks of the study, medication will be increased to a daily dose
of 20 mg of fluoxetine or placebo. If, at Week 4, a participant continues to demonstrate
significant depressive symptoms, medication will be increased to 30 mg daily. All
participants will also receive Treatment as Usual (TAU) during the acute phase of the trial,
which will consist of motivation enhancement therapy (MET) and Cognitive Behavioral Therapy
(CBT). Outcome measures will be obtained at screening, baseline, and weekly intervals for
the first four weeks of the treatment phase; they will then be obtained biweekly for the
final 8 weeks of the treatment phase. Blood will be drawn at baseline and at Weeks 4, 8, and
12 to assess the level of three liver enzymes (Gamma-glutamyl Transferase (gGTP), Aspartate
aminotransferase (SGOT), and Alanine aminotransferase (SGPT)). This will provide a
biochemical monitoring of drinking behavior and medication compliance. The 12-week acute
phase study will be supplemented by a 9-month naturalistic follow-up phase, during which
care will be transferred from the study provider to the community provider. The study will
end with a 1-year follow-up evaluation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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