- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04221997
Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders. (EV-SoPRANO)
September 13, 2023 updated by: Jeffrey Strawn, MD, University of Cincinnati
Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heidi K Schroeder, BS
- Phone Number: 513-558-4422
- Email: heysehk@uc.edu
Study Contact Backup
- Name: Zoe A Neptune, BS
- Phone Number: 513-558-2866
- Email: neptunza@uc.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Withdrawn
- University of Columbia, New York State Psychiatric Institute
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Recruiting
- University of Cincinnati
-
Contact:
- Heidi K Schroeder, BS
- Phone Number: 513-558-4422
- Email: heysehk@uc.edu
-
Principal Investigator:
- Jeffrey R Strawn, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sertraline
90 patients will be randomized to sertraline
|
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
Other Names:
|
Placebo Comparator: Placebo
30 patient will be randomized to placebo
|
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
Other Names:
|
No Intervention: Healthy Control
30 healthy comparison subjects will be followed over the course of 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey R Strawn, MD, FAACAP, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
January 6, 2020
First Submitted That Met QC Criteria
January 6, 2020
First Posted (Actual)
January 9, 2020
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Selective Serotonin Reuptake Inhibitors
- Sertraline
Other Study ID Numbers
- Strawn EV-SoPRANO
- R01HD098757 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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