Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
NCT ID: NCT01302080
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
941 participants
OBSERVATIONAL
2012-04-04
2020-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sertraline-treated
enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline
sertraline
Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
psychotherapy only
enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy
psychotherapy
Non-interventional study- as above
Interventions
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sertraline
Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
psychotherapy
Non-interventional study- as above
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
6 Years
16 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Harmonex Neuroscience Research
Dothan, Alabama, United States
Sun Valley Research Center
Imperial, California, United States
UCLA Semel institute
Los Angeles, California, United States
Institute of Living/Hartford Hospital
Hartford, Connecticut, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Nemours Children's Clinic, Dept. of Psychology and Psychiatry
Jacksonville, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Harmonex Neuroscience of Pensacola
Pensacola, Florida, United States
University of South Florida - Rothman Center
St. Petersburg, Florida, United States
Georgia Regents University Augusta
Augusta, Georgia, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, United States
Family Behavioral Health
Plainfield, Illinois, United States
University of Kansas School of Medicine/Dept. of Psychiatry
Kansas City, Kansas, United States
Family Service and Guidance Center
Topeka, Kansas, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Neuroscientific Insights
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Debora A. LaMonica, MD
South Yarmouth, Massachusetts, United States
Baystate Medical Center, Child Behavioral Health Research
Springfield, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, United States
Saint John's Clinic
Springfield, Missouri, United States
Jersey Shore University Medical Center/Meridian Health
Neptune City, New Jersey, United States
Children's Specialized Hospital
Toms River, New Jersey, United States
Finger Lakes Clinical Research
Rochester, New York, United States
3-C Family Services, P.A.
Cary, North Carolina, United States
Duke University Medical Center, Division of Child & Adolescent Psychiatry
Durham, North Carolina, United States
Scott George Crowder, M.D.
Wilmington, North Carolina, United States
Family Center by the Falls
Chagrin Falls, Ohio, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital and Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Department of Psychiatry Child/Adolescent
Cleveland, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Child Guidance Resource Center
Havertown, Pennsylvania, United States
Tullahoma Pediatrics PLLC
Tullahoma, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Bay Pointe Behavioral Health Service, Inc.
Friendswood, Texas, United States
Midtown Psychiatry and TMS Center
Houston, Texas, United States
Peter Ly MD
Houston, Texas, United States
Focus and Balance, LLC
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Clinical Research Partners, LLC
Petersburg, Virginia, United States
McLean Hospital - Harvard Medical School
Milwaukee, Wisconsin, United States
Countries
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References
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Kolitsopoulos F, Ramaker S, Compton SN, Broderick S, Orazem J, Bao W, Lokhnygina Y, Marschall K, Chappell P. Effects of Long-Term Sertraline Use on Pediatric Growth and Development: The Sertraline Pediatric Registry for The Evaluation of Safety (SPRITES). J Child Adolesc Psychopharmacol. 2023 Feb;33(1):2-13. doi: 10.1089/cap.2022.0048.
Kolitsopoulos F, Ramaker S, Compton S, Broderick S, Orazem J, Bao W, Lokhnygina Y, Chappell P. Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline. J Child Adolesc Psychopharmacol. 2021 Aug;31(6):411-420. doi: 10.1089/cap.2020.0170. Epub 2021 Jul 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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SPRITES
Identifier Type: OTHER
Identifier Source: secondary_id
A0501093
Identifier Type: -
Identifier Source: org_study_id