- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00149643
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence (CADY)
Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD
- DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS
- Marijuana use of at least two days within the week prior to enrollment
- Demonstrated adequate levels of depressive symptoms within the week prior to enrollment
Exclusion Criteria:
- DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia
- Hypo or hyperthyroidism
- Significant cardiac, neurological, or kidney impairment
- Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level)
- Use of antipsychotic or antidepressant medication in the month prior to enrollment
- DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use
- History of significant medication side effects from any SSRI antidepressant
- Pregnant
- Unable to use adequate contraceptive methods for the duration of the study
- Inability to read or understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fluoxetine
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 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.
Other Names:
|
Placebo Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days Per Week of Cannabis Use.
Time Frame: 12 Weeks
|
The number days out of the last seven days that cannabis was used.
|
12 Weeks
|
Depression Symptoms at Week 12
Time Frame: 12 Weeks
|
Average of Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10 and 12.
The BDI is a subject reported measure that has a minimim score of 0 and a maximum score of 63.
A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scare (63).
Each DSM-IV criteron asses a different depressive symptom.
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.
Time Frame: 12 Weeks
|
Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jack R Cornelius, University of Pittsburgh at Pittsburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Marijuana Abuse
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- NIDA-19142-1
- DPMC (Other Identifier: NIDA)
- R01DA019142 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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