Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

• Status: Completed
• Trial end date: 2020-09-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Sertraline

Criteria

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

• Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant