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

NCT ID: NCT04221997

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2026-09-30

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

sertraline

90 patients will be randomized to sertraline

Group Type: EXPERIMENTAL

sertraline

Intervention Type: DRUG

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

Placebo

30 patient will be randomized to placebo

Group Type: PLACEBO_COMPARATOR

sertraline

Intervention Type: DRUG

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

Healthy Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sertraline

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

Intervention Type: DRUG

Other Intervention Names

Zoloft

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Strawn, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey R Strawn, MD, FAACAP

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heidi K Schroeder, BS

Role: CONTACT

heysehk@uc.edu

513-558-4422

Zoe A Neptune, BS

Role: CONTACT

neptunza@uc.edu

513-558-2866

Facility Contacts

Heidi K Schroeder, BS

Role: primary

heysehk@uc.edu

513-558-4422

Other Identifiers

R01HD098757

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Strawn EV-SoPRANO

Identifier Type: -

Identifier Source: org_study_id