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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 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.

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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.

Interventions

  • DRUG sertraline
  • BEHAVIORAL psychotherapy

Trial Details

FieldValue
Enrollment Target 941 participants
Start Date 2012-04-04
Est. Completion 2020-09-09

What the Registry Record Tells You About NCT01302080

The ClinicalTrials.gov registry entry for NCT01302080 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 941 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which sertraline is the first listed.

NCT01302080 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.