Trials / Completed
CompletedNCT01302080
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 941 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sertraline | Non interventional study - drug, dose, duration etc as per USPI and clinician discretion |
| BEHAVIORAL | psychotherapy | Non-interventional study- as above |
Timeline
- Start date
- 2012-04-04
- Primary completion
- 2020-09-09
- Completion
- 2020-09-09
- First posted
- 2011-02-23
- Last updated
- 2021-10-14
- Results posted
- 2021-10-08
Locations
44 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01302080. Inclusion in this directory is not an endorsement.