Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Study ID
A0501093

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Jessica Jones
214/456-5926
jessica.jones@utsouthwestern.edu

Principal Investigator
Graham Emslie

Official Title

Sprites: Sertraline Pediatric Registry For The Evaluation Of Safety

Brief Overview


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.

Summary


Purposive sample: patients are not randomly selected, that is, he or she must meet certain
inclusion criteria in order to qualify as a potential study participant.

Participant Eligibility


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