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Sequential Treatment With Fluoxetine and Relapse-Prevention CBT to Improve Outcomes in Pediatric Depression
Betsy D. Kennard, Psy.D.; Graham J. Emslie, M.D.; Taryn L. Mayes, M.S.; Paul A. Nakonezny, Ph.D.; Jessica M. Jones, M.A.; Aleksandra A. Foxwell, Ph.D.; Jessica King, B.A.
Am J Psychiatry 2014;171:1083-1090. doi:10.1176/appi.ajp.2014.13111460
View Author and Article Information

Dr. Emslie receives research support from Eli Lilly, BioMarin, Somerset, Duke University, Forest Laboratories, Valeant, GlaxoSmithKline, and Mylan; is a consultant for Allergan, Biobehavioral Diagnostics Company, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, INC Research, Lundbeck, Merck, Pfizer, Seaside Therapeutics, Shire, Texas Department of State Health Services, University of Miami, and Valeant; and is on the speakers bureau for Forest Laboratories. The other authors report no financial relationships with commercial interests.

Supported by NIMH grant R01 MH39188 (principal investigators, Dr. Emslie and Dr. Kennard).

From the Department of Psychiatry and the Department of Clinical Sciences, Division of Biostatistics, University of Texas Southwestern Medical Center, Dallas; and Children’s Medical Center of Dallas.

Presented in part at the 60th annual meeting of the American Academy of Child and Adolescent Psychiatry, Lake Buena Vista, Fla., October 22–27, 2013; the 53rd annual meeting of the New Clinical Drug Evaluation Unit, Hollywood, Fla., May 28–31, 2013; the 15th International Congress of the European Society for Child and Adolescent Psychiatry, Dublin, July 6–10, 2013; and the Eighth International Conference on Child and Adolescent Psychopathology, London, July 15–17, 2013.

Address correspondence to Dr. Kennard (beth.kennard@utsouthwestern.edu).

Copyright © 2014 by the American Psychiatric Association

Received November 05, 2013; Revised April 02, 2014; Revised April 21, 2014; Accepted April 24, 2014.

Abstract

Objective  The authors evaluated a sequential treatment strategy of fluoxetine and relapse-prevention cognitive-behavioral therapy (CBT) to determine effects on remission and relapse in youths with major depressive disorder.

Method  Youths 8–17 years of age with major depression were treated openly with fluoxetine for 6 weeks. Those with an adequate response (defined as a reduction of 50% or more on the Children’s Depression Rating Scale–Revised [CDRS-R]) were randomly assigned to receive continued medication management alone or continued medication management plus CBT for an additional 6 months. The CBT was modified to address residual symptoms and was supplemented by well-being therapy. Primary outcome measures were time to remission (with remission defined as a CDRS-R score of 28 or less) and rate of relapse (with relapse defined as either a CDRS-R score of 40 or more with a history of 2 weeks of symptom worsening, or clinical deterioration).

Results  Of the 200 participants enrolled in acute-phase treatment, 144 were assigned to continuation treatment with medication management alone (N=69) or medication management plus CBT (N=75). During the 30-week continuation treatment period, time to remission did not differ significantly between treatment groups (hazard ratio=1.26, 95% CI=0.87, 1.82). However, the medication management plus CBT group had a significantly lower risk of relapse than the medication management only group (hazard ratio=0.31, 95% CI=0.13, 0.75). The estimated probability of relapse by week 30 was lower with medication management plus CBT than with medication management only (9% compared with 26.5%).

Conclusions  Continuation-phase relapse-prevention CBT was effective in reducing the risk of relapse but not in accelerating time to remission in children and adolescents with major depressive disorder.

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FIGURE 1. Remission Survival Curve After 30 Weeks for Youths With Depression Receiving Either Medication Management Only or Medication Management Plus Cognitive-Behavioral Therapy (CBT)a

a Participants received acute-phase treatment with fluoxetine for 6 weeks, after which they were randomly assigned to receive continuation treatment with medication management only or medication management plus CBT for 24 weeks.

FIGURE 2. Relapse Survival Curve After 30 Weeks for Youths With Depression Receiving Either Medication Management Only or Medication Management Plus Cognitive-Behavioral Therapy (CBT)

a Participants received acute-phase treatment with fluoxetine for 6 weeks, after which they were randomly assigned to receive continuation treatment with medication management only or medication management plus CBT for 24 weeks.

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TABLE 1.Description of Relapse-Prevention Cognitive-Behavioral Therapy
Table Footer Note

a Six general areas of wellness: self-acceptance, social, success, self-goals, spiritual, and soothing. Using a wellness log designed for relapse-prevention cognitive-behavioral therapy, the therapist assessed for existing strengths and areas of improvement. The wellness aspect of the treatment resulted in the development of an individualized wellness plan for each patient.

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TABLE 2.Demographic and Clinical Characteristics of Youths With Depression Receiving Either Medication Management Only or Medication Management Plus Cognitive-Behavioral Therapy (CBT)a
Table Footer Note

a Participants received acute-phase treatment with fluoxetine for 6 weeks, after which they were randomly assigned to receive continuation treatment with medication management only or medication management plus CBT for 24 weeks. CGI=Clinical Global Impressions Scale; CDRS-R=Children’s Depression Rating Scale–Revised.

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