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A0501093: SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY: A Non-Interventional, Longitudinal, Cohort Study to Evaluate the Effects of Long-Term Sertraline Treatment in Children and Adolescents

Principal Investigator:

The primary objectives are to evaluate the long-term impact of treatment with sertraline on aspects of cognition, emotional and physical development, and pubertal maturation. Secondary objectives include:

(1) evaluating the relative risks and benefits of long-term sertraline exposure and
(2) identifying predictors of the impact of sertraline on cognitive, emotional, and physical and pubertal maturation over time

A total of 900 subjects (720 exposed to sertraline as prescribed by their physician [with or without psychotherapy] and 180 exposed to psychotherapy alone) age 6 to 14 (inclusive) will be enrolled in the study over a 2-year period.

Study visits will take place at baseline, 12 weeks, 6 months, and every 6 months thereafter for 3 years. At each study visit, cognition, emotional and physical development, and pubertal maturation will be assessed.

Kennedy Krieger Institute Announces Retirement of President and CEO

Dr. Gary W. GoldsteinThe Institute’s board of directors is conducting a national search and is expected to name a new CEO in the coming months.
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