Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
Condition: Depressive Disorder, Major; Cannabis Abuse
MeSH terms: Marijuana Abuse; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fluoxetine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Gelatin capsules Fluoxetine 10 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20 mg, 2 capsules barring side effects.; Gelatin capsules Placebo capsules, identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis; MDD