Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

April 01, 2012
Mental Health, Pediatrics
Bruce Waslick, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.

Ages Eligible for Study: 6 Years to 16 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:
• Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.

Exclusion Criteria:
• Psychotic at study entry
• Diagnosis of bipolar disorder
• Diagnosis of schizoaffective or schizophrenia
• Anorexia
• Bulimia or eating disorder not otherwise specified (NOS)
• Autism
• Pervasive developmental disorder
• High risk of suicide within 2 weeks of initiating study treatment
• Significant mental retardation

Bruce Waslick, MD