Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

Study Overview
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Brief Summary
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This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.

Detailed Description
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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.

Official Title
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Continuation Phase CBT for Youth With MDD

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)
* Drug: Drug therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry Clinical Global Impression severity score of 4 or greater Children's Depression Rating Scale score of 40 or greater Currently attending school Willing and able to use acceptable methods of contraception, if applicable In good general health Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: History of psychotic disorders Alcohol or substance abuse or dependence within 6 months prior to study entry History of anorexia nervosa or bulimia Chronic medical illness requiring regular medication Current use of medication with psychotropic effects First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder At risk for suicide Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks) IQ less than 80 Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response | Behavioral: Cognitive behavioral therapy (CBT)<br>* 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.<br>Drug: Drug therapy<br>* 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).<br>* Other names: fluoxetine;|
| Active Comparator: 2<br>Continuation phase drug therapy only for 6 more months following acute treatment response | Drug: Drug therapy<br>* 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).<br>* Other names: fluoxetine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of depressive symptoms |  | Measured at Months 3 and 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Adolescent, CBT, Drug Therapy