Depression
Conditions
Keywords
Child, Adolescent, CBT, Drug Therapy
Brief summary
This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.
Detailed description
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.
Interventions
BEHAVIORALCognitive behavioral therapy (CBT)
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.
DRUGDrug therapy
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).
Sponsors
National Institute of Mental Health (NIMH)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse of depressive symptoms | Measured at Months 3 and 9 |
Countries
United States
Outcome results
None listed