CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Fluoxetine +1 moredrug
Likely dose
Fluoxetine 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00612313
NCT00612313N/ACompleted
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Pediatric MDD: Sequential Treatment With Fluoxetine and Relapse Prevention

University of Texas Southwestern Medical Center·interventional·Posted Feb 11, 2008·Updated Jan 7, 2016

In Brief

A clinical study evaluating Fluoxetine and Relapse prevention cognitive behavioral therapy (CBT) for Depression. Completed, enrolled 144 participants across 1 site.

Detailed Summary

This study will compare the effectiveness of fluoxetine alone with the effectiveness of fluoxetine with cognitive behavioral therapy in increasing recovery and preventing relapse in youth with major depressive disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.4 years ago

Interventions

Fluoxetinedrug

Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.

Relapse prevention cognitive behavioral therapy (CBT)behavioral

After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.