Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders. (EV-SoPRANO)

University of Cincinnati

Status and phase: Enrolling; Phase 4

Conditions: Anxiety Disorders

Treatments: Drug: sertraline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04221997

R01HD098757 (U.S. NIH Grant/Contract)

Strawn EV-SoPRANO

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

sertraline

Experimental group

Description:

90 patients will be randomized to sertraline

Treatment:

Drug: sertraline

Placebo

Placebo Comparator group

Description:

30 patient will be randomized to placebo

Treatment:

Drug: sertraline

Healthy Control

No Intervention group

Description:

30 healthy comparison subjects will be followed over the course of 12 weeks