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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
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.