Clinical Trial: Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00158301

Purpose

This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing a relapse of depressive symptoms in children.
Condition Intervention Phase
Depression
 Behavior: Cognitive behavioral therapy
 Drug: Drug therapy
Phase I

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Continuation Phase CBT for Youth with MDD

Further Study Details: 
Primary Outcomes: Relapse of depressive symptoms
Expected Total Enrollment:  60

Study start: September 2004;  Expected completion: October 2007
Last follow-up: September 2007;  Data entry closure: October 2007

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 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.

Eligibility

Ages Eligible for Study:  11 Years   -   18 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158301


Texas
      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  75390,  United States; Recruiting
Beth D. Kennard, PsyD  214-648-4403    beth.kennard@utsouthwestern.edu 
Taryn L. Mayes, MS  214-648-4379    taryn.mayes@utsouthwestern.edu 
Beth D. Kennard, PsyD,  Principal Investigator
Graham J. Emslie, MD,  Sub-Investigator

Study chairs or principal investigators

Beth D. Kennard, PsyD,  Principal Investigator,  University of Texas   

More Information

Study ID Numbers:  1R34-MH07273701
Last Updated:  September 10, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00158301
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13



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