Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Viatris

Status

Completed

Conditions

Obsessive Compulsive Disorder

Treatments

Drug: sertraline

Behavioral: psychotherapy

Study type

Observational

Funder types

Industry

Identifiers

NCT01302080

A0501093

SPRITES (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

941 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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