Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence (CADY)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00149643
First received: September 6, 2005
Last updated: June 17, 2013
Last verified: June 2013

September 6, 2005
June 17, 2013
September 2004
August 2009   (final data collection date for primary outcome measure)
  • Days Per Week of Cannabis Use. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The number days out of the last seven days that cannabis was used.
  • Depression Symptoms at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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.
  • Marijuana use; measured at Weeks 1-4, 6, 8, 10, 12 and 52
  • Depressive condition; measured at Weeks 1-4, 6, 8, 10, 12 and 52
  • Effectiveness of fluoxetine for treating marijuana dependence and major depressive disorder; measured at Weeks 1-4, 6, 8, 10, 12 and 52
Complete list of historical versions of study NCT00149643 on ClinicalTrials.gov Archive Site
Number of Cannabis Use Disorder Criterion Met at a Particular Time Point. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.
Not Provided
Not Provided
Not Provided
 
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Disorder, Major
  • Cannabis Abuse
  • 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
  • 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.
  • 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.
    Intervention: Drug: Fluoxetine
  • 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.
    Intervention: Other: Placebo
Cornelius JR, Bukstein OG, Douaihy AB, Clark DB, Chung TA, Daley DC, Wood DS, Brown SJ. Double-blind fluoxetine trial in comorbid MDD-CUD youth and young adults. Drug Alcohol Depend. 2010 Nov 1;112(1-2):39-45. doi: 10.1016/j.drugalcdep.2010.05.010. Epub 2010 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2012
August 2009   (final data collection date for primary outcome measure)

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
Both
14 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149643
NIDA-19142-1, R01DA019142, DPMC
Yes
Jack Cornelius, University of Pittsburgh
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jack R Cornelius University of Pittsburgh at Pittsburgh
University of Pittsburgh
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP