Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety Disorders
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: During the acute treatment phase, 90 patients will be randomized to sertraline and 30 patients will be randomized to placebo (3:1).Masking: Double (Participant, Investigator)Masking Description: Double BlindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 17 years
- Gender
- Both males and females
Description
Randomized, double-blind, placebo-controlled trial of an evidence-based antidepressant, sertraline, in youth (N=120) with generalized, separation and/or social anxiety disorders, seeks to evaluate the predictive value of plasma EV signatures. Patients will be randomized to sertraline (25-200 mg/day)...
Randomized, double-blind, placebo-controlled trial of an evidence-based antidepressant, sertraline, in youth (N=120) with generalized, separation and/or social anxiety disorders, seeks to evaluate the predictive value of plasma EV signatures. Patients will be randomized to sertraline (25-200 mg/day) or placebo (3:1) and total plasma EVs will be collected at baseline and serially during the course of the 12-week treatment period.
Tracking Information
- NCT #
- NCT04221997
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Principal Investigator: Jeffrey R Strawn, MD, FAACAP University of Cincinnati
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