Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00149643 |
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.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder, Major Marijuana Abuse |
Drug: Fluoxetine Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People |
Estimated Enrollment: | 212 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
|
Drug: Fluoxetine
Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
|
2: Placebo Comparator
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.
|
Drug: Placebo
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.
|
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-GTP, SGOT, and 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.
Ages Eligible for Study: | 14 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jack R. Cornelius, M.D., M.P.H. | 412-246-5189 | jcornel+@pitt.edu |
United States, Pennsylvania | |
Department of Psychiatry | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Jeanine M. Hayes, R.N. 412-246-5189 hayesJM@upm.edu | |
Contact: Maribeth A. Wesesky, C.M.A. 412-246-6906 weseskyma@upmc.edu | |
Principal Investigator: Jack R. Cornelius, M.D., M.P.H. |
Principal Investigator: | Jack R Cornelius | University of Pittsburgh at Pittsburgh |
Responsible Party: | University of Pittsburgh ( Jack R. Cornelius, M.D., M.P.H. ) |
Study ID Numbers: | NIDA-19142-1, R01-19142-1, DPMC |
Study First Received: | September 6, 2005 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00149643 |
Health Authority: | United States: Federal Government |
Cannabis MDD |
Fluoxetine Depression Mental Disorders Mood Disorders Substance-Related Disorders Disorders of Environmental Origin |
Depressive Disorder, Major Depressive Disorder Marijuana Abuse Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |