Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders. (EV-SoPRANO)

  • End date
    Sep 24, 2024
  • participants needed
  • sponsor
    University of Cincinnati
Updated on 24 March 2022
social phobia
Accepts healthy volunteers


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


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.

Condition Anxiety Disorders
Treatment Sertraline
Clinical Study IdentifierNCT04221997
SponsorUniversity of Cincinnati
Last Modified on24 March 2022


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
vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant
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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