An interventional study of Cognitive behavioral therapy (CBT) and Drug therapy in Depression, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-11-08.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.
Depression is a chronic and episodic condition that may have devastating effects on social and emotional functioning, particularly in the pediatric population. While approximately 90% of children eventually recover from an episode of depression, up to 40% of those children relapse within 1 to 2 years. Data indicate that cognitive behavioral therapy (CBT) delivered after depressive symptoms subside can significantly reduce depression relapses in adults. However, there are no comparable studies in children or adolescents. This study will determine whether CBT is effective in reducing a relapse of depressive episodes in children and adolescents with major depression.
This study comprises two phases. In Phase 1, all participants will receive drug treatment for 12 weeks. Participants who respond to the treatment will complete the study after 12 weeks. Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2. In Phase 2, participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months. The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms. Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 72 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response
Behavioral: Cognitive behavioral therapy (CBT) · Drug: Drug therapy
Continuation phase drug therapy only for 6 more months following acute treatment response
Drug: Drug therapy
CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms.
All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
Also known as: fluoxetine
Relapse of depressive symptoms
Time frame: Measured at Months 3 and 9
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center