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Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence (CADY)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), July 2008
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00149643
  Purpose

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

MedlinePlus related topics: Depression Marijuana
Drug Information available for: Fluoxetine Cannabis GW-1000 Fluoxetine hydrochloride Gelatin
U.S. FDA Resources
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

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Marijuana use [ Time Frame: Measured at Weeks 1-4, 6, 8, 10, 12 and 1 year ] [ Designated as safety issue: No ]
  • Depressive condition [ Time Frame: Measured at Weeks 1-4, 6, 8, 10, 12, and 1 yr. ] [ Designated as safety issue: No ]

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.

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-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.

  Eligibility

Ages Eligible for Study:   14 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149643

Contacts
Contact: Jack R. Cornelius, M.D., M.P.H. 412-246-5189 jcornel+@pitt.edu

Locations
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.            
Sponsors and Collaborators
Investigators
Principal Investigator: Jack R Cornelius University of Pittsburgh at Pittsburgh
  More Information

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

Keywords provided by National Institute on Drug Abuse (NIDA):
Cannabis
MDD

Study placed in the following topic categories:
Fluoxetine
Depression
Mental Disorders
Mood Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Depressive Disorder, Major
Depressive Disorder
Marijuana Abuse
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009