NCT04221997

Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.

Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Accepted

Summary

A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.

Detailed 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) or placebo (3:1) and total plasma EVs will be collected at baseline and serially during the course of the 12-week treatment period.

Conditions

• Anxiety Disorders

Interventions

Type	Name	Description
DRUG	sertraline	Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)

Timeline

• Start date: 2019-11-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2020-01-09
• Last updated: 2024-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study