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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Depressive Disorder, Major; Cannabis Abuse	Drug: Fluoxetine; Other: Placebo	Phase 2

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 Design

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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

Arms and Interventions

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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.	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
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.	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.

Outcome Measures

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Primary Outcome Measures :

1. Days Per Week of Cannabis Use. [ Time Frame: 12 Weeks ]
   The number days out of the last seven days that cannabis was used.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 25 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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Locations

United States, Pennsylvania
Department of Psychiatry
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Jack R Cornelius	University of Pittsburgh at Pittsburgh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Responsible Party:	Jack Cornelius, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00149643 History of Changes
Other Study ID Numbers:	NIDA-19142-1; R01DA019142 ( U.S. NIH Grant/Contract ); DPMC
First Posted:	September 8, 2005
Results First Posted:	September 3, 2012
Last Update Posted:	June 24, 2013
Last Verified:	June 2013

Keywords provided by Jack Cornelius, University of Pittsburgh:

Cannabis; MDD

Additional relevant MeSH terms:

Depressive Disorder; Depression; Marijuana Abuse; 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