NCT00158301

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

3.2 years

First QC Date

September 7, 2005

Last Update Submit

November 7, 2013

Conditions

Depression

Keywords

ChildAdolescentCBTDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Relapse of depressive symptoms

    Measured at Months 3 and 9

Study Arms (2)

1

EXPERIMENTAL

Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response

Behavioral: Cognitive behavioral therapy (CBT)Drug: Drug therapy

2

ACTIVE COMPARATOR

Continuation phase drug therapy only for 6 more months following acute treatment response

Drug: Drug therapy

Interventions

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.

1
Drug therapyDRUG

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).

Also known as: fluoxetine
12

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.

    PMID: 20973714DERIVED

  • Kennard BD, Emslie GJ, Mayes TL, Nightingale-Teresi J, Nakonezny PA, Hughes JL, Jones JM, Tao R, Stewart SM, Jarrett RB. Cognitive-behavioral therapy to prevent relapse in pediatric responders to pharmacotherapy for major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1395-404. doi: 10.1097/CHI.0b013e31818914a1.

    PMID: 18978634DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral TherapyDrug TherapyFluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsPropylaminesAminesOrganic Chemicals

Study Officials

  • Beth D. Kennard, PsyD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Primary Completion

November 1, 2007

Study Completion

February 1, 2008

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

US(1)