Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Completed
Conditions studied: Obsessive Compulsive Disorder
In brief
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.
Key facts
- Study ID
- NCT01302080
- Run by
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- People needed
- 941
- Starts
- 2012-04-04
- Expected to finish
- 2020-09-09
- Last updated by the study team
- 2021-10-14
Who can join
Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 generation antipsychotic, lithium, psychostimulant
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.