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Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Graham Emslie, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00612313
First received: February 7, 2008
Last updated: June 26, 2013
Last verified: June 2013

February 7, 2008
June 26, 2013
February 2008
February 2013   (final data collection date for primary outcome measure)
  • Remission [ Time Frame: Measured at Weeks 6, 12, 18, 24, and 30 ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: Measured at Weeks 6, 12, 18, 24, and 30 ] [ Designated as safety issue: No ]
  • Remission [ Time Frame: Measured at Weeks 6, 12, 18, 24, 30, 52, and 78 ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: Measured at Weeks 6, 12, 18, 24, 30, 52, and 78 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00612313 on ClinicalTrials.gov Archive Site
  • K-Life (percent time well and percent time ill) [ Time Frame: Measured at Weeks 6, 12, 18, 24, 30, 52, and 78 ] [ Designated as safety issue: No ]
  • Remission [ Time Frame: Weeks 52 and 78 ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: Weeks 52 and 78 ] [ Designated as safety issue: No ]
K-Life (percent time well and percent time ill) [ Time Frame: Measured at Weeks 6, 12, 18, 24, 30, 52, and 78 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse
Pediatric MDD: Sequential Treatment With Fluoxetine and Relapse Prevention

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.

Major depressive disorder (MDD) is a serious psychiatric disorder that affects approximately 1 out of every 12 to 15 children and adolescents. Depression can cause problems with school, family, and friends, and if left untreated, these difficulties can persist into adulthood. Treatments using antidepressants and forms of psychotherapy have been shown to be effective in reducing symptoms of depression. However, many youth experience a return of depressive symptoms within 1 to 2 years of remission. Recent studies have shown that adding cognitive behavioral therapy (CBT), a form of psychotherapy that focuses on behavioral modification, to initial antidepressant treatment may increase remission and reduce relapse rates. This study will compare the effectiveness of fluoxetine alone versus fluoxetine plus added CBT in increasing recovery and preventing relapse in youth with MDD.

Participation in this study will last 78 weeks. Potential participants will undergo initial screening, which will include interviews and questionnaires about mood, behavior, and medical history; vital sign measurements; a meeting with a psychiatrist; and lab draws and/or urine drug or pregnancy tests if indicated by the psychiatrist. All eligible participants will then begin 6 weeks of treatment with fluoxetine. During this 6-week period, participants will attend weekly study visits, which will include vital sign measurements, questionnaires on symptoms and mood, and medication dosage adjustments. At Week 6, participants will be evaluated by an independent evaluator who will determine whether their depression has significantly improved. Participants who have not improved with fluoxetine will end their study participation and will be provided with recommendations for other treatment options.

All participants who have shown significant improvement will continue to receive fluoxetine for another 24 weeks, for a total of 30 weeks of treatment. Half of these participants will be randomly assigned to additionally receive CBT for the remaining 24 weeks. All participants will attend study visits that will occur every other week for 3 months and then monthly for 3 months. These visits will last 20 to 30 minutes and will include vital sign measurements and questions about mood and behavior. Participants receiving CBT will also attend 10 to 12 CBT sessions, which will last 50 minutes each and will occur weekly for the first 4 weeks, every other week for 1.5 months, and monthly for the last 3 months. The CBT sessions will involve both individual child and parent-child sessions, which will focus on modifying depressive thoughts, feelings, and behaviors. Participants will undergo repeat evaluations with the independent evaluator at Weeks 12, 18, 24, 30, 52, and 78.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: Fluoxetine
    Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
    Other Name: Prozac
  • Behavioral: Relapse prevention cognitive behavioral therapy (CBT)
    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.
    Other Name: CBT
  • Active Comparator: Continued medication alone
    Participants will receive antidepressant treatment with fluoxetine for 30 weeks
    Intervention: Drug: Fluoxetine
  • Experimental: Continued medication plus CBT
    Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment
    Interventions:
    • Drug: Fluoxetine
    • Behavioral: Relapse prevention cognitive behavioral therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2014
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612313
R01 MH039188-01, R01MH039188-01, DSIR 84-CTS
Yes
Graham Emslie, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: 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
University of Texas Southwestern Medical Center
June 2013

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