Biomarkers of Antidepressant Treatment in Adoloescents with Major Depression

Primary Investigator: Ian A. Cook, M.D. - Major depressive disorder (MDD) is one of the most common, disabling, and costly conditions, and when it arises during childhood or adolescence, the impact on cognitive and emotional development can have long-lasting consequences. Many adolescents with MDD do not respond to an initial trial of and SSRI antidepressant, and the difference between placebo and medication response rates in this age group is often smaller than in trials for adults with MDD. Some adolescents exposed to antidepressant medication experience treatment-emergent suicidal ideation, so the balance of risks and benefits of antidepressants for adolescents may be different than for adults. A biomarker that could help identify which individuals would benefit from pharmacotherapy could aid in the management of MDD in this age group. Since the 1990s, our laboratory has worked to discover and refine physiologic biomarkers based on EEG changes arising in the first week of treatment. Work with our cordance biomarker has been independently replicated by other investigators. As a further refinement, the BRITE-MD trial (Biomarkers for Rapid Identification of Treatment Effectiveness in Major Depression) found that data from a 15 minute office-based EEG could predict 7 week remission with 74% accuracy, superior to clinical and genetic markers. All these trials have excluded individuals under the age of 18, so accuracy of any of our EEG biomarkers in adolescents and children is unknown. We propose a pilot study of 26 adolescents with MDD, age 14-18, to evaluate the performance of two biomarkers, early changes in prefrontal cordance, and the Antidepressant Treatment Response index (ATR) as used in the BRITE-MD trial. Subjects will receive 12 8 weeks of double-blinded treatment with fluoxetine (FLX) or placebo, with EEG data recorded prior to and serially during treatment. Outcome measures will be symptomatic and functional improvement. We will evaluate the relationship between these physiologic biomarkers and treatment outcome in this new patient population. This project will integrate research efforts now on-going in several components of the Integrative Study Center on Mood Disorders: the Unipolar Depression Research Program, the Laboratory of Brain, Behavior, and Pharmacology, and the Division of Child and Adolescent Psychiatry.

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