Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
University of Cincinnati · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT04221997
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 8–17 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 150
- US sites recruiting
- 1
- Study start
- November 1, 2019
- Record last updated
- November 1, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Being studied: sertraline
Conditions: Anxiety Disorders
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
University of Cincinnati
Cincinnati, OH 45219
Site contact: Heidi K Schroeder, BS · 513-558-4422 · heysehk@uc.edu
Study contacts (from the official record)
- Heidi K Schroeder, BS · 513-558-4422 · heysehk@uc.edu
- Zoe A Neptune, BS · 513-558-2866 · neptunza@uc.edu
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