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Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

NCT01302080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 941

Last updated 2021-10-14

Study results available
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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.

Conditions

  • Obsessive Compulsive Disorder

Interventions

DRUG

sertraline

Non interventional study - drug, dose, duration etc as per USPI and clinician discretion

BEHAVIORAL

psychotherapy

Non-interventional study- as above

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-04
Primary Completion
2020-09-09
Completion
2020-09-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302080 on ClinicalTrials.gov