NCT04221997 Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
| NCT ID | NCT04221997 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Cincinnati |
| Condition | Anxiety Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-11-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2019-11-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Eligibility 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.
Contact & Investigator
Jeffrey R Strawn, MD, FAACAP
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT04221997 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Anxiety Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04221997 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04221997 currently recruiting?
Yes, NCT04221997 is actively recruiting participants. Contact the research team at heysehk@uc.edu for enrollment information.
Where is the NCT04221997 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04221997 clinical trial?
NCT04221997 is sponsored by University of Cincinnati. The principal investigator is Jeffrey R Strawn, MD, FAACAP at University of Cincinnati. The trial plans to enroll 150 participants.
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