Skip to main content
OpenTrials
Completed

NCT Number: NCT00158301

Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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 therapy

Drug

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 names: fluoxetine

Primary outcomes

  1. Relapse of depressive symptoms

    Time frame: Measured at Months 3 and 9

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Continuation Phase CBT for Youth With MDD

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.