CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Fluoxetine +1 moredrug
Likely dose
Fluoxetine 10–20 mg daily (gelatin capsules, 1–2 capsules orally each morning)AI-extracted
Key inclusion· 4
  • DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD
  • DSM-IV diagnosis of current major depressive disorder, confirmed by K-SADS
  • Marijuana use at least two days within the week prior to enrollment
  • Demonstrated adequate levels of depressive symptoms within the week prior to enrollment
Key exclusion· 8
  • 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)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00149643
NCT00149643Phase 2Completed

Fluoxetine for Major Depressive Disorder/Cannabis Disorder in Young People

University of Pittsburgh·interventional·Posted Sep 8, 2005·Updated Jun 24, 2013

In Brief

A Phase 2 clinical trial evaluating Fluoxetine and Placebo for Depressive Disorder, Major and Cannabis Abuse. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartSep 1, 2004
Primary CompletionAug 1, 2009
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.8 years ago

Interventions

Fluoxetinedrug

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.

Placeboother

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.