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Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders. | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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)

NCT04221997•University of Cincinnati

View on ClinicalTrials.gov

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.

Eligibility

Age

8 - 17 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Written, informed assent and consent.
•Patients, parent/guardian/LAR must be fluent in the English.
•8-17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
•Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID with no lifetime history of mania, OCD or significant history of trauma exposure.
•PARS score ≥15 at Visits 1 and 2.
•Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product.
•No clinically significant abnormalities on physical examination.
•Negative pregnancy test at Visit 1 in females.
•Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and within 30 days following the end of study participation.
•Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted.
+16 more criteria

Exclusion Criteria

•Subjects Co-occurring DSM-5 diagnosis mood (except persistent depressive disorder, unspecified depressive disorder or co- occurring anxiety disorders, provided that the primary diagnosis is generalized, social and/or separation anxiety disorder(s)), eating, bipolar, or psychotic disorders.
•A history of treatment with SSRIs within 12 weeks of Visit 2 (Baseline) or current pharmacotherapy with CNS effects that require \>5 half-lives for discontinuation.
•A history of major neurological or medical illness or head trauma with loss of consciousness for ≥5 minutes.
•Lifetime history of mania, OCD, or significant history of trauma exposure.
•History of hypersensitivity to sertraline.
•Lifetime diagnosis of intellectual disability or history of IQ \<70.
•History of alcohol/substance use disorder or any substance abuse within the past 6 months (nicotine dependence is permitted).
•Current psychotherapy stable for \<2 months prior to Visit 2 (Baseline).
•Females will not be eligible to participate if they are pregnant, breast feeding or lactating.
•The subject lives \>100 miles from the University of Cincinnati or \>90 minutes from the CU site or is not able to attend the follow-up visits.
+2 more criteria

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

November 1, 2019

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

November 1, 2024

Enrollment

150

ESTIMATED participants

Conditions

Anxiety Disorders

Interventions

sertraline

DRUG

Contacts

Heidi K Schroeder, BS

CONTACT

513-558-4422 heysehk@uc.edu

Zoe A Neptune, BS

CONTACT

513-558-2866 neptunza@uc.edu

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AnxietyAnxiety Disorders

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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