Clinical trial NCT00149643: Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
Official title: Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Cannabis Abuse
Keywords: Cannabis
MDD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-08
Enrollment: 70
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Days Per Week of Cannabis Use.
timeFrame: 12 Weeks
measure: Depression Symptoms at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Department of Psychiatry
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh at Pittsburgh
name: Jack R Cornelius
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.