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

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ClinicalTrials.gov Identifier: NCT04221997
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jeffrey Strawn, MD, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: sertraline 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : November 1, 2019
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: Zoloft

No Intervention: Healthy Control
30 healthy comparison subjects will be followed over the course of 12 weeks



Primary Outcome Measures :
  1. Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2 [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221997


Contacts
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Contact: Heidi K Schroeder, BS 513-558-4422 heysehk@ucmail.uc.edu
Contact: Ashley M Specht, BBA 513-558-2868 huckabam@ucmail.uc.edu

Locations
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United States, New York
University of Columbia, New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Amir Levine, MD    646-774-7331      
Principal Investigator: Amir Levine, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Ashley Specht    513-558-2868    huckabam@ucmail.uc.edu   
Principal Investigator: Jeffrey R Strawn,, MD         
Sponsors and Collaborators
University of Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jeffrey R Strawn, MD, FAACAP University of Cincinnati
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Responsible Party: Jeffrey Strawn, MD, Associate professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04221997    
Other Study ID Numbers: Strawn EV-SoPRANO
R01HD098757 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Anxiety Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs