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

Depressive Disorder, Major Clinical Trial

— CADY  

Official title:

Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149643
• Other study ID #: NIDA-19142-1
• Secondary ID: R01DA019142DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: June 17, 2013
• Start date: September 2004
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Abuse
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Marijuana Abuse

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Department of Psychiatry	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days Per Week of Cannabis Use.	The number days out of the last seven days that cannabis was used.	12 Weeks	No
Primary	Depression Symptoms at Week 12	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	No
Secondary	Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.	Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.	12 Weeks	No