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

NCT04221997 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: Strawn EV-SoPRANOR01HD098757
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2

  Primary response outcome will be treatment response based on patients having attained a score on the Clinical Global Impression-Improvement Scale ≤ 2 at Week 12 or Last-Observation-Carried-Forward (LOCF).

  Week 12

Study Arms (3)

sertraline

EXPERIMENTAL

90 patients will be randomized to sertraline

Drug: sertraline

Placebo

PLACEBO COMPARATOR

30 patient will be randomized to placebo

Drug: sertraline

Healthy Control

NO INTERVENTION

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

Interventions

sertraline DRUG

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

Also known as: Zoloft

Placebo; sertraline

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written, informed assent and consent.
• Patients, parent/guardian/LAR must be fluent in the English.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jeffrey R Strawn, MD, FAACAP

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi K Schroeder, BS

CONTACT

513-558-4422; heysehk@uc.edu

Zoe A Neptune, BS

CONTACT

513-558-2866; neptunza@uc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: During the acute treatment phase, 90 patients will be randomized to sertraline and 30 patients will be randomized to placebo (3:1).

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: November 1, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)