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
  Purpose

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.


Condition Intervention
Depression
Drug: Fluoxetine
Behavioral: Relapse prevention cognitive behavioral therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric MDD: Sequential Treatment With Fluoxetine and Relapse Prevention

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: February 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continued medication alone
Participants will receive antidepressant treatment with fluoxetine for 30 weeks
Drug: Fluoxetine
Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.
Other Name: Prozac
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612313

Locations
United States, Texas
Children's Medical Center of Dallas, Outpatient Psychiatry Clinic
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Graham Emslie, Professor of Psychiatry, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00612313     History of Changes
Obsolete Identifiers: NCT00599300
Other Study ID Numbers: R01 MH039188-01, R01MH039188-01, DSIR 84-CTS
Study First Received: February 7, 2008
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Texas Southwestern Medical Center:
Major Depressive Disorder
MDD
Children
Adolescents
Antidepressant
CBT

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on April 17, 2014