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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Sertraline

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.