Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
8 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
150 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for
This trial is looking for young people ages 8 to 17 who have anxiety disorders like generalized, separation, or social anxiety. Participants will take a medication called sertraline and help researchers understand how it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 8 and 17 years old.
I have a parent or guardian who can help me.
I have been diagnosed with generalized, social, or separation anxiety disorder.
I have a PARS score of 15 or higher at my first two visits.
I understand and agree to participate in this trial.
My caregiver will monitor my safety and provide information.
I do not have any significant health issues.
I can provide a negative pregnancy test if I am female.
You may not be able to join if
I have been treated for mood or psychotic disorders.
I have taken SSRIs in the last 12 weeks.
I have a history of major medical issues or head trauma.
I have a history of mania or OCD.
I am currently pregnant or breastfeeding.
I live too far from the study site.
I cannot swallow capsules.
I am considered at risk of suicide.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Trial Locations
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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 se…
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.
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