RecruitingAnxiety Disorders
Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
Eligible age
8–17 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Sponsor: University of Cincinnati
You may qualify if…
- ✓ 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.
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).
Where it's recruiting
Ohio
Cincinnati
Source: ClinicalTrials.gov · NCT04221997 · last updated 2024-11-01