Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Last updated: October 12, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

N/A

Condition

Obsessive-compulsive Disorder

Mood Disorders

Kleptomania

Treatment

N/A

Clinical Study ID

NCT01302080
A0501093
SPRITES
  • Ages 6-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsivedisorder, receiving treatment in outpatient setting, and who are prescribed a newprescription for sertraline to treat one of the above study-qualifying disorders orbeginning psychotherapy for same.

Exclusion

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 generationantipsychotic, lithium, psychostimulant

Study Design

Total Participants: 941
Study Start date:
April 04, 2012
Estimated Completion Date:
September 09, 2020

Study 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.

Connect with a study center

  • Harmonex Neuroscience Research

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Sun Valley Research Center

    Imperial, California 92251
    United States

    Site Not Available

  • Stramski Children's Developmental Center

    Long Beach, California 90806
    United States

    Site Not Available

  • UCLA Semel institute

    Los Angeles, California 90024
    United States

    Site Not Available

  • PCSD Feighner Research

    San Diego, California 92108
    United States

    Site Not Available

  • Private Practice

    Solana Beach, California 92075
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045-7106
    United States

    Site Not Available

  • Institute of Living/Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Comprehensive Psychiatric Care

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Nemours Children's Clinic, Dept. of Psychology and Psychiatry

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Medical Research Group of Central Florida

    Orange City, Florida 32763
    United States

    Site Not Available

  • Harmonex Neuroscience of Pensacola

    Pensacola, Florida 32502
    United States

    Site Not Available

  • University of South Florida - Rothman Center

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • All Children's Hospital

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Georgia Regents University Augusta

    Agusta, Georgia 30912
    United States

    Site Not Available

  • Georgia Regents University Augusta

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Institute for Behavioral Medicine, LLC

    Smyrna, Georgia 30080
    United States

    Site Not Available

  • The Psych Associates of DuPage Chartered

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Family Behavioral Health

    Plainfield, Illinois 60585
    United States

    Site Not Available

  • Rosalind Franklin University Health System

    Vernon Hills, Illinois 60061
    United States

    Site Not Available

  • University of Kansas School of Medicine/Dept. of Psychiatry

    Kansas City, Kansas 66160-7341
    United States

    Site Not Available

  • Family Service and Guidance Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Kennedy Krieger Institute

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Private Practice

    Ellicott City, Maryland 21042
    United States

    Site Not Available

  • Neuroscientific Insights

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Debora A. LaMonica, MD

    South Yarmouth, Massachusetts 02664
    United States

    Site Not Available

  • Baystate Medical Center, Child Behavioral Health Research

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Comprehensive Psychiatric Associates

    Gladstone, Missouri 64118
    United States

    Site Not Available

  • Saint John's Clinic

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Jersey Shore University Medical Center/Meridian Health

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Jersey Shore University Medical Center/Meridian Health

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Children's Specialized Hospital

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Columbia University Clinic for Anxiety and Related Disorders (CUCARD)

    New York, New York 10019
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • 3-C Family Services, P.A.

    Cary, North Carolina 27513
    United States

    Site Not Available

  • Duke University Medical Center, Division of Child & Adolescent Psychiatry

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Scott George Crowder, M.D.

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Family Center by the Falls

    Chagrin Falls, Ohio 44023
    United States

    Site Not Available

  • Cincinnati Childrens Hospital and Medical Center

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • University Of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Case Western Reserve University, Department of Psychiatry Child/Adolescent

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Child Guidance Resource Center

    Havertown, Pennsylvania 19083
    United States

    Site Not Available

  • Tullahoma Pediatrics PLLC

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • Bay Pointe Behavioral Health Service, Inc.

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Midtown Psychiatry and TMS Center

    Houston, Texas 77007
    United States

    Site Not Available

  • Peter Ly MD

    Houston, Texas 77058
    United States

    Site Not Available

  • Focus and Balance, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottsville, Virginia 22903
    United States

    Site Not Available

  • Clinical Research Partners, LLC

    Petersburg, Virginia 23805
    United States

    Site Not Available

  • McLean Hospital - Harvard Medical School

    Milwaukee, Wisconsin 53227
    United States

    Site Not Available

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