Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
CADY
Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People
3 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
September 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 24, 2013
June 1, 2013
4.9 years
September 6, 2005
February 8, 2012
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Days Per Week of Cannabis Use.
The number days out of the last seven days that cannabis was used.
12 Weeks
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
Secondary Outcomes (1)
Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.
12 Weeks
Study Arms (2)
Fluoxetine
ACTIVE COMPARATORGelatin 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.
Placebo
PLACEBO COMPARATORGelatin 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Department of Psychiatry
Pittsburgh, Pennsylvania, 15213, United States
Related 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 2010 Jun 23.
PMID: 20576364RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jack R. Cornelius, M.D.
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Jack R Cornelius
University of Pittsburgh at Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
September 1, 2004
Primary Completion
August 1, 2009
Study Completion
December 1, 2012
Last Updated
June 24, 2013
Results First Posted
September 3, 2012
Record last verified: 2013-06