Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse
Completed · Not applicable
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT00612313
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 144
- Starts
- 2008-02-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2016-01-07
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Primary diagnosis of nonpsychotic MDD (single or recurrent) for at least 4 weeks before study entry
- In good general medical health
- Normal intelligence
You may not qualify if…
- Lifetime history of any psychotic disorder, including psychotic depression
- Lifetime history of bipolar I and II disorders
- Alcohol or substance dependence within the 6 months before study entry
- Anorexia nervosa or bulimia within the 6 months before study entry
- Pregnant or breastfeeding females, or sexually active females not using medically acceptable means of birth control (e.g., IUD, birth control pills, barrier devices)
- Chronic medical illness (medically unstable and requires regular medication that may interfere with treatment interventions)
- Concurrent medication(s) with psychotropic effects (e.g., anticonvulsants, steroids, etc.) other than stable ADHD medication
- First degree relatives with bipolar I disorder
- Severe suicidal ideation or previous history of serious suicide attempt within this episode
- Prior failure to respond to an adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
- Non-English speaking
Where it is running
- Children's Medical Center of Dallas, Outpatient Psychiatry Clinic — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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