Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 16 |
| Updated: | 12/27/2018 |
| Start Date: | April 2012 |
| End Date: | October 2020 |
SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY A NON-INTERVENTIONAL, LONGITUDINAL, COHORT STUDY TO EVALUATE THE EFFECTS OF LONG-TERM SERTRALINE TREATMENT IN CHILDREN AND ADOLESCENTS
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.
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.
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.
inclusion criteria in order to qualify as a potential study participant.
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.
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
We found this trial at
44
sites
Durham, North Carolina 27705
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Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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