Phase 2
Completed N=70
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
Depressive Disorder, Major · Cannabis Abuse
Source: ClinicalTrials.gov NCT00149643 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Days Per Week of Cannabis Use. — 3.88; 3.1 Days of cannabis use per week — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days Per Week of Cannabis Use. |
3.88; 3.1 | <0.05 sig |
| PRIMARY Depression Symptoms at Week 12 |
7.79; 7.31 | — |
| SECONDARY Number of Cannabis Use Disorder Criterion Met at a Particular Time Point. |
0.59; 0.47 | — |
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
Data sourced from ClinicalTrials.gov (NCT00149643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.