NCT01302080 (SPRITES) is a clinical trial of sertraline in Obsessive Compulsive Disorder, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Who is sponsoring NCT01302080?

NCT01302080 is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

What drugs are being tested in NCT01302080?

Interventions in NCT01302080: sertraline, psychotherapy.

What condition does NCT01302080 study?

NCT01302080 studies Obsessive Compulsive Disorder.

Is NCT01302080 still recruiting?

NCT01302080 is currently completed. Last updated 14 October 2021.

Are results published for NCT01302080?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-14 · How we verify

NCT01302080: SPRITES

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Completed Results posted Last updated 14 October 2021

What this trial tests

trial testing sertraline in Obsessive Compulsive Disorder in 941 participants. Completed in 9 September 2020.

Timeline

4 April 2012

Primary endpoint
9 September 2020

9 September 2020

Quick facts

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	941
Start date	4 April 2012
Primary completion	9 September 2020
Estimated completion	9 September 2020
Sites	44 locations across United States

Drugs / interventions tested

sertraline (sertraline) — full drug profile →
psychotherapy

Conditions studied

Obsessive Compulsive Disorder — all drugs for Obsessive Compulsive Disorder →

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →

Who can join

Adults 6 to 16, any sex, with Obsessive Compulsive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES).
Kolitsopoulos F, Ramaker S, Compton SN, Broderick S, et al · · 2023 · cited 6× · PMID 36799958 · DOI 10.1089/cap.2022.0048
Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline.
Kolitsopoulos F, Ramaker S, Compton S, Broderick S, et al · · 2021 · cited 3× · PMID 34287023 · DOI 10.1089/cap.2020.0170

Verify or expand the search:

Other trials of sertraline

Trials testing the same drug.

NCT05341843 — Sertraline Effect in Uremic Pruritis · Phase 2 · completed
NCT04963257 — Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder · Phase 4 · unknown
NCT04183205 — Predicting SSRI Efficacy in Veterans With PTSD · Phase 4 · terminated
NCT03511118 — Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants · recruiting

Other recruiting trials for Obsessive Compulsive Disorder

Currently open trials in the same condition.

NCT07011901 — Precision Analytic Research Methods in OCD · NA · recruiting
NCT04631042 — Developing Brain, Impulsivity and Compulsivity · recruiting
NCT03184454 — Combined Cortical/Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorde · NA · active not recruiting

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

Trials by the same sponsor.

NCT04391868 — A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form · Phase 1 · withdrawn
NCT04176367 — An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactu · Phase 1 · completed
NCT03768726 — Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents · Phase 3 · terminated
NCT03711708 — Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets · Phase 4 · completed
NCT03342690 — Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01302080 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last refreshed: 14 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01302080.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing