Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00158301
First received: September 7, 2005
Last updated: November 7, 2013
Last verified: November 2013

September 7, 2005
November 7, 2013
September 2004
November 2007   (final data collection date for primary outcome measure)
Relapse of depressive symptoms [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]
Relapse of depressive symptoms
Complete list of historical versions of study NCT00158301 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents
Continuation Phase CBT for Youth With MDD

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • Behavioral: Cognitive 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.
  • Drug: Drug 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).
    Other Name: fluoxetine
  • Experimental: 1
    Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response
    Interventions:
    • Behavioral: Cognitive behavioral therapy (CBT)
    • Drug: Drug therapy
  • Active Comparator: 2
    Continuation phase drug therapy only for 6 more months following acute treatment response
    Intervention: Drug: Drug therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
February 2008
November 2007   (final data collection date for primary outcome measure)

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
Both
11 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158301
R34 MH72737, R34MH072737, DSIR 84-CTS
Yes
Beth Kennard, PsyD, UT Southwestern Medical Center
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Beth D. Kennard, PsyD University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP