Anxiety & Depression Association of America

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.

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.