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

Official title

Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)

Overview

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

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.

Interventions

• Drug sertraline
  Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)

Primary outcome measures

• Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2 [Time frame: Week 12]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Cincinnati — Cincinnati

Identifiers

NCT: NCT04221997 · Strawn EV-SoPRANO · R01HD098757

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗