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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2024
  • participants needed
    150
  • sponsor
    University of Cincinnati
Updated on 24 March 2022
anxiety
psychosis
sertraline
social phobia
Accepts healthy volunteers

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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note