Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
April 01, 2012
315572
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
Active
Observational
Bruce Waslick, MD
413-794-7035