Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence (CADY)
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| ClinicalTrials.gov Identifier: NCT00149643 |
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Recruitment Status :
Completed
First Posted : September 8, 2005
Results First Posted : September 3, 2012
Last Update Posted : June 24, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depressive Disorder, Major Cannabis Abuse | Drug: Fluoxetine Other: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | August 2009 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: 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.
Other Name: Prozac |
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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.
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Other: 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. |
- Days Per Week of Cannabis Use. [ Time Frame: 12 Weeks ]The number days out of the last seven days that cannabis was used.
- 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.
- 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.
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| Ages Eligible for Study: | 14 Years to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149643
| United States, Pennsylvania | |
| Department of Psychiatry | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Jack R Cornelius | University of Pittsburgh at Pittsburgh |
| Responsible Party: | Jack Cornelius, Professor of Psychiatry, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00149643 |
| Other Study ID Numbers: |
NIDA-19142-1 R01DA019142 ( U.S. NIH Grant/Contract ) DPMC |
| First Posted: | September 8, 2005 Key Record Dates |
| Results First Posted: | September 3, 2012 |
| Last Update Posted: | June 24, 2013 |
| Last Verified: | June 2013 |
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Cannabis MDD |
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Marijuana Abuse Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Substance-Related Disorders Chemically-Induced Disorders Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |