Actively Recruiting
Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
Led by University of Cincinnati · Updated on 2024-11-01
150
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
CONDITIONS
Official Title
Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written, informed assent and consent.
- Patient and parent/guardian/LAR must be fluent in English.
- Age 8 to 17 years inclusive at Visit 1 with a parent/guardian/LAR.
- For anxiety patients: meet DSM-5 criteria for generalized, social and/or separation anxiety disorder confirmed by MINI-KID, with no lifetime history of mania, OCD, or significant trauma exposure.
- PARS score 15 or higher at Visits 1 and 2.
- Caregiver willing to oversee safety monitoring and provide patient information.
- No clinically significant abnormalities on physical exam.
- Negative pregnancy test at Visit 1 for females.
- Sexually active females must use reliable contraception during and for 30 days after the study.
- Reliable contraception methods include surgical sterilization, oral contraceptives, transdermal contraceptives, depot injections, vaginal rings, contraceptive implants, intrauterine devices, or diaphragm plus condom.
- For healthy controls: no history of DSM-5 disorders except nicotine or adjustment disorder.
- Negative pregnancy test and urine drug screen at screening for females.
- No first-degree relatives with affective, anxiety, or psychotic disorders.
- Caregiver willing to oversee safety monitoring and provide patient information.
- No clinically significant abnormalities on physical exam.
You will not qualify if you...
- Co-occurring DSM-5 mood disorders (except persistent depressive disorder, unspecified depressive disorder, or co-occurring anxiety disorders if primary diagnosis is anxiety), eating, bipolar, or psychotic disorders.
- SSRI treatment within 12 weeks before baseline or current CNS-active pharmacotherapy requiring more than 5 half-lives discontinuation.
- Major neurological or medical illness or head trauma with loss of consciousness over 5 minutes.
- Lifetime history of mania, OCD, or significant trauma exposure.
- Hypersensitivity to sertraline.
- Intellectual disability or IQ less than 70.
- Alcohol or substance use disorder or any substance abuse within past 6 months (nicotine dependence allowed).
- Psychotherapy started less than 2 months before baseline.
- Females who are pregnant, breastfeeding, or lactating.
- Living more than 100 miles from University of Cincinnati or more than 90 minutes from CU site or unable to attend follow-ups.
- Unable to swallow capsules.
- Considered at risk of suicide or inappropriate risk for participation by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
H
Heidi K Schroeder, BS
CONTACT
Z
Zoe A Neptune, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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