Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

(SPRITES Trial)

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility 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.

Treatment Details

Interventions

• Psychotherapy (Behavioral Intervention)
• Sertraline (Selective Serotonin Reuptake Inhibitor)

Participant Groups

Group I: psychotherapy only Experimental Treatment 1 Intervention

enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy

Group II: Sertraline-treated Experimental Treatment 1 Intervention

enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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

Lead Sponsor

Trials

435

Recruited

407,000+

Dr. Sanjeev Narula

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

Chief Medical Officer

MD from Harvard Medical School

Scott A. Smith

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

Chief Executive Officer since 2023

BSc in Chemistry and Biology, Honors BSc in Pharmacology and Toxicology from Western University, MBA from Thunderbird School of Global Management