Treatment of anxiety disorders in youth using sertraline

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

This study is testing if the antidepressant sertraline can help young people aged 8-17 with different types of anxiety disorders feel better over 12 weeks.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 8 Years to 17 Years
• Sex: All
• Sponsor: University of Cincinnati (other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT04221997 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of sertraline, an antidepressant, in treating youth aged 8-17 with generalized, separation, and/or social anxiety disorders. It is a multicenter, randomized, double-blind, placebo-controlled study involving 120 participants who will receive either sertraline or a placebo over a 12-week period. The study also aims to assess the predictive value of plasma extracellular vesicle signatures in relation to treatment outcomes. Participants will be monitored for safety and efficacy throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are youth aged 8-17 diagnosed with generalized, separation, or social anxiety disorders.

Not a fit: Patients with a history of mania, OCD, or significant trauma exposure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve anxiety symptoms in youth, enhancing their quality of life.

How similar studies have performed: Previous studies have shown positive outcomes with sertraline in treating anxiety disorders, indicating a promising approach.

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.

Where this trial is running

Cincinnati, Ohio

• University of Cincinnati — Cincinnati, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Jeffrey R Strawn, MD, FAACAP — University of Cincinnati
• Study coordinator: Heidi K Schroeder, BS

Conditions: Anxiety Disorders