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

STATUS

Recruiting
days left to enroll

10
participants needed

150
sponsor

University of Cincinnati

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Updated on 19 February 2024

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anxiety

sertraline

psychosis

estrogen

progestin

separation

urine drug screen

social phobia

norplant

mania

nuvaring

evra

implanon

adjustment disorder

oral contraceptives

Summary

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

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.

Details

Condition	ANXIETY NEUROSIS
Age	8-17 years
Treatment	sertraline
Clinical Study Identifier	NCT04221997
Sponsor	University of Cincinnati
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Written, informed assent and consent
	Patients, parent/guardian/LAR must be fluent in the English
	-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
	surgical sterilization
	oral contraceptives (e.g., estrogen-progestin combination or progestin)
	transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g
	Depo-Provera)
	vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant
	II/Jadelle)
	an intrauterine device or
	diaphragm plus condom
	Inclusion Criteria for Healthy Controls
	Written, informed assent and consent
	Patients, parent/guardian/LAR must be fluent in the English
	to 17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR
	No history of any DSM-5 disorders (nicotine use disorder is permitted, history of adjustment disorder is permitted), confirmed by the MINI-KID
	Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient
	No clinically significant abnormalities on physical examination. Negative pregnancy test at Screening in females
	Negative urine drug screen at Screening
	No first-degree relatives with an affective, anxiety or psychotic disorder
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
	Patients who are unable to swallow capsules
	Is currently considered at risk of suicide in the opinion of the investigator, represents an inappropriate risk to the participant and/or could confound the interpretation of the study results

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