At a glance
ClinicalIndex Comparison RecordN/ACompleted· 941 enrolled
Drug / intervention
sertraline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·observational·Posted Feb 23, 2011·Updated Oct 14, 2021
In Brief
An observational study evaluating sertraline and psychotherapy for Obsessive Compulsive Disorder. Completed, enrolled 941 participants across 44 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObsessive Compulsive Disorder
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartApr 2012
Primary CompletionSep 2020
TodayJul 2026
First PostedFeb 23, 2011
Enrollment StartApr 4, 2012
Primary CompletionSep 9, 2020
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 15.4 years ago
Interventions
sertralinedrug
Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
psychotherapybehavioral
Non-interventional study- as above