NCT00612313

Brief Summary

This study will compare the effectiveness of fluoxetine alone with the effectiveness of fluoxetine with cognitive behavioral therapy in increasing recovery and preventing relapse in youth with major depressive disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2008

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 17, 2014

Completed
Last Updated

January 7, 2016

Status Verified

December 1, 2015

Enrollment Period

5 years

First QC Date

February 7, 2008

Results QC Date

July 3, 2014

Last Update Submit

December 3, 2015

Conditions

Depression

Keywords

Major Depressive DisorderMDDChildrenAdolescentsAntidepressantCBT

Outcome Measures

Primary Outcomes (3)

  • Time to Remission

    Remission is defined as CDRS-R \<=28. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.

    30 weeks

  • Relapse

    Relapse was defined as: 1\) CDRS-R score \>=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R\<40, but with a 2 week history of significant clinical deterioration.

    Measured at Weeks 12, 18, 24, and 30

  • Remission

    Remission is defined as CDRS-R \<=28.

    Measured at Weeks 12, 18, 24, and 30

Secondary Outcomes (3)

  • K-Life (Time Well)

    30 weeks

  • Remission

    Weeks 52 and 78

  • Relapse

    Weeks 52 and 78

Study Arms (2)

Continued medication alone

ACTIVE COMPARATOR

Participants will receive antidepressant treatment with fluoxetine for 30 weeks

Drug: Fluoxetine

Continued medication plus CBT

EXPERIMENTAL

Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment

Drug: FluoxetineBehavioral: Relapse prevention cognitive behavioral therapy (CBT)

Interventions

FluoxetineDRUG

Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.

Also known as: Prozac
Continued medication aloneContinued medication plus CBT
Relapse prevention cognitive behavioral therapy (CBT)BEHAVIORAL

After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.

Also known as: CBT
Continued medication plus CBT

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Primary diagnosis of nonpsychotic MDD (single or recurrent) for at least 4 weeks before study entry
  • In good general medical health
  • Normal intelligence

You may not qualify if:

  • Lifetime history of any psychotic disorder, including psychotic depression
  • Lifetime history of bipolar I and II disorders
  • Alcohol or substance dependence within the 6 months before study entry
  • Anorexia nervosa or bulimia within the 6 months before study entry
  • Pregnant or breastfeeding females, or sexually active females not using medically acceptable means of birth control (e.g., IUD, birth control pills, barrier devices)
  • Chronic medical illness (medically unstable and requires regular medication that may interfere with treatment interventions)
  • Concurrent medication(s) with psychotropic effects (e.g., anticonvulsants, steroids, etc.) other than stable ADHD medication
  • First degree relatives with bipolar I disorder
  • Severe suicidal ideation or previous history of serious suicide attempt within this episode
  • Prior failure to respond to an adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center of Dallas, Outpatient Psychiatry Clinic

Dallas, Texas, 75235, United States

Location

Related Publications (4)

  • Kennard BD, Emslie GJ, Mayes TL, Nakonezny PA, Jones JM, Foxwell AA, King J. Sequential treatment with fluoxetine and relapse--prevention CBT to improve outcomes in pediatric depression. Am J Psychiatry. 2014 Oct;171(10):1083-90. doi: 10.1176/appi.ajp.2014.13111460.

    PMID: 24935082RESULT

  • Croarkin PE, Nakonezny PA, Morris DW, Rush AJ, Kennard BD, Emslie GJ. Performance and Psychometric Properties of Novel Brief Assessments for Depression in Children and Adolescents. JAACAP Open. 2024 May 27;3(2):335-343. doi: 10.1016/j.jaacop.2024.05.002. eCollection 2025 Jun.

    PMID: 40520979DERIVED

  • Emslie GJ, Kennard BD, Mayes TL, Nakonezny PA, Moore J, Jones JM, Foxwell AA, King J. Continued Effectiveness of Relapse Prevention Cognitive-Behavioral Therapy Following Fluoxetine Treatment in Youth With Major Depressive Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):991-8. doi: 10.1016/j.jaac.2015.09.014. Epub 2015 Oct 8.

    PMID: 26598474DERIVED

  • Croarkin PE, Nakonezny PA, Husain MM, Port JD, Melton T, Kennard BD, Emslie GJ, Kozel FA, Daskalakis ZJ. Evidence for pretreatment LICI deficits among depressed children and adolescents with nonresponse to fluoxetine. Brain Stimul. 2014 Mar-Apr;7(2):243-51. doi: 10.1016/j.brs.2013.11.006. Epub 2013 Dec 3.

    PMID: 24360599DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Limitations and Caveats

* Primary outcomes based on data through 30 weeks. * Participants were not blinded to treatment assignment.

Results Point of Contact

Title
Dr. Graham Emslie and Dr. Betsy Kennard
Organization
UT Southwestern Medical Center
beth.kennard@utsouthwestern.edu
214-456-5900

Study Officials

  • Graham J. Emslie, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

  • Beth D. Kennard, PsyD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 11, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2013

Study Completion

January 1, 2014

Last Updated

January 7, 2016

Results First Posted

December 17, 2014

Record last verified: 2015-12

Locations

US(1)