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

Sponsor
University of Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT04221997
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
150
2
3
58
75
1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
During the acute treatment phase, 90 patients will be randomized to sertraline and 30 patients will be randomized to placebo (3:1).During the acute treatment phase, 90 patients will be randomized to sertraline and 30 patients will be randomized to placebo (3:1).
Masking:
Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose:
Basic Science
Official Title:
Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: sertraline

90 patients will be randomized to sertraline

Drug: sertraline
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
Other Names:
  • Zoloft
  • Placebo Comparator: Placebo

    30 patient will be randomized to placebo

    Drug: sertraline
    Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
    Other Names:
  • Zoloft
  • No Intervention: Healthy Control

    30 healthy comparison subjects will be followed over the course of 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2 [Week 12]

      Primary response outcome will be treatment response based on patients having attained a score on the Clinical Global Impression-Improvement Scale ≤ 2 at Week 12 or Last-Observation-Carried-Forward (LOCF).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria for Patients with Anxiety :
    • 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.

    • 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.

    • 8 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 for Patients with Anxiety Disorders and Healthy Comparison:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Columbia, New York State Psychiatric Institute New York New York United States 10032
    2 University of Cincinnati Cincinnati Ohio United States 45219

    Sponsors and Collaborators

    • University of Cincinnati
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Jeffrey R Strawn, MD, FAACAP, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeffrey Strawn, MD, Associate professor, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT04221997
    Other Study ID Numbers:
    • Strawn EV-SoPRANO
    • R01HD098757
    First Posted:
    Jan 9, 2020
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2022