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NCT01302080 · ClinicalTrials.gov registry record
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
A clinical trial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- 941
- Enrollment target
NCT01302080: Completed study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01302080 is a clinical trial that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 941 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302080 has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- 941 participants
- Enrollment target
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.
Primary Outcome
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to
Interventions
- DRUG sertraline
- BEHAVIORAL psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 941 participants |
| Start Date | 2012-04-04 |
| Est. Completion | 2020-09-09 |
What the finished NCT01302080 record still lists
NCT01302080 is an observational study that tracks outcomes without assigning an intervention. The registered 941 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which sertraline is the first listed.
NCT01302080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01302080 about?
NCT01302080 is a clinical study titled "Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)". 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.
What is the current status of trial NCT01302080?
This trial is currently completed. The enrollment target is 941 participants. The study started on 2012-04-04. Estimated completion is 2020-09-09.
What interventions are being tested in trial NCT01302080?
The interventions under investigation include: sertraline (DRUG), psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01302080?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
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