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

Strawn EV-SoPRANO

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

2019-11-01

2024-09-01

2024-09-01

Recruiting

Early phase I

150

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.

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2023-09-14