Cognitive-behavioral therapy to prevent relapse in pediatric responders to pharmacotherapy for major depressive disorder

Abstract

Objective: We present results of a feasibility test of a sequential treatment strategy using continuation phase cognitive-behavioral therapy (CBT) to prevent relapse in youths with major depressive disorder (MDD) who have responded to acute phase pharmacotherapy.

Method: Forty-six youths (ages 11-18 years) who had responded to 12 weeks of treatment with fluoxetine were randomized to receive either 6 months of continued antidepressant medication management (MM) or antidepressant MM plus relapse prevention CBT (MM+CBT). Primary outcome was time to relapse, defined as a Childhood Depression Rating Scale-Revised score of 40 or higher and 2 weeks of symptom worsening or clinical deterioration warranting alteration of treatment to prevent full relapse.

Results: Cox proportional hazards regression, adjusting for depression severity at randomization and for the hazard of relapsing by age across the trial, revealed that participants in the MM treatment group had a significantly greater risk for relapse than those in the MM+CBT treatment group (hazard ratio = 8.80; 95% confidence interval 1.01-76.89; chi = 3.86, p =.049) during 6 months of continuation treatment. In addition, patient satisfaction was significantly higher in the MM+CBT group. No differences were found between the two treatment groups on attrition rate, serious adverse events, and overall global functioning.

Conclusions: These preliminary results suggest that continuation phase CBT reduces the risk for relapse by eightfold compared with pharmacotherapy responders who received antidepressant medication alone during the 6-month continuation phase.

Trial registration: ClinicalTrials.gov NCT00158301.

Conflict of interest statement

Disclosure: Dr. Emslie receives research support from the National Institute of Mental Health, Eli Lilly, Organon, Shire, Somerset, Forest Laboratories, and Biobehavioral Diagnostics; is a consultant for Eli Lilly, Forest Laboratories, GlaxoSmithKline, Wyeth-Ayerst, Shire, and Biobehavioral Diagnostics; and is on the speakers’ bureau for McNeil. The other authors report no conflicts of interests.

Figures

Fig. 1

Consort diagram.

Fig. 2

Survival curves, plotted at the mean of all covariates in the model, showing the survival probability (of not relapsing) at a given week across the trial for the MM+CBT and MM treatment groups. The survival model, comparing MM+CBT with MM, included the following continuously measured covariates: CDRS-R total score at randomization and age across the trial. CDRS-R = Children’s Depression Rating Scale-Revised; MM= antidepressant medication management; MM+CBT = antidepressant medication management plus relapse prevention cognitive-behavioral therapy.