Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antidepressive Agents; Fluoxetine

Criteria

Inclusion Criteria:

• Primary diagnosis of nonpsychotic MDD (single or recurrent) for at least 4 weeks before study entry

• In good general medical health

• Normal intelligence

Exclusion Criteria:

• 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