Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse
Condition: Depression
MeSH terms: Recurrence; Depression
Study type: Interventional

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.
    

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.
    

Intervention name(s): Fluoxetine; Relapse prevention cognitive behavioral therapy (CBT)
Intervention type(s): Drug; Behavioral
Intervention description(s): Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.; 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 intervention name(s): Prozac; CBT
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Children; Adolescents; Antidepressant; CBT