RecruitingPhase 4NCT04221997

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)


Sponsor

University of Cincinnati

Enrollment

150 participants

Start Date

Nov 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether sertraline (an antidepressant also used for anxiety) is effective and safe for children and teenagers aged 8 to 17 who suffer from anxiety disorders such as generalized anxiety, social anxiety, or separation anxiety. **You may be eligible if...** - Your child is between 8 and 17 years old - Your child has been diagnosed with generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder - Your child scores above a certain threshold on an anxiety rating scale - Your child and parent/guardian can communicate in English - A caregiver is available to monitor and oversee the child's participation - Your child does not have a history of mania or serious trauma **You may NOT be eligible if...** - Your child has a history of bipolar disorder or mania - Your child is currently pregnant - Adequate contraception is not in place for sexually active participants - Your child is unable to attend study visits or follow the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsertraline

Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)


Locations(1)

University of Cincinnati

Cincinnati, Ohio, United States

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NCT04221997


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