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

Phase 4

Recruiting

• Conditions: Anxiety Disorders
• Interventions: Drug: sertraline

• Registration Number: NCT04221997
• Lead Sponsor: University of Cincinnati

Brief 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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sertraline	sertraline	90 patients will be randomized to sertraline
Placebo	sertraline	30 patient will be randomized to placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2	Week 12	Primary response outcome will be treatment response based on patients having attained a score on the Clinical Global Impression-Improvement Scale ≤ 2 at Week 12 or Last-Observation-Carried-Forward (LOCF).

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States