Clinical trial NCT04221997: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anxiety Disorders
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-01-09
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Primary outcomes:
measure: Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jeffrey R Strawn, MD, FAACAP
role: PRINCIPAL_INVESTIGATOR
References: