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Sertraline for Anxiety in Youth

This study is testing sertraline, an antidepressant (a type of medicine that helps with mood), for young people aged 8 to 17 who have generalized, separation, or social anxiety disorders. Sertraline is part of a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The study aims to see if sertraline helps improve anxiety symptoms. To join, you must be between 8 and 17 years old, speak English, and have a parent or guardian who also speaks English. The study will look at how many participants show improvement in their anxiety after 12 weeks. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either sertraline or a placebo (an inactive substance), and neither you nor your doctor will know which you are receiving. About 150 participants are planned for this study.
What's involved
You would receive sertraline (25-200 mg/day) or a placebo for 12 weeks. Blood samples will be collected at the beginning of the study and several times during the 12-week treatment period.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 12, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04221997

Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.

Recruiting
PHASE4Ages 8–17InterventionalBasic science
University of Cincinnati
~150 participants
Updated 2024-11-01 on ClinicalTrials.gov
What's tested:sertraline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
Measured over Week 12

Conditions

Anxiety Disorders

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NCT04221997

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Cincinnati

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeffrey R Strawn, MD, FAACAP · PRINCIPAL_INVESTIGATOR · University of Cincinnati

Who to contact

Heidi K Schroeder, BS
[email protected]
513-558-4422
Email the study team

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2Week 12

    Primary response outcome will be treatment response based on patients having attained a score on the Clinical Global Impression-Improvement Scale ≤ 2 at Week 12 or Last-Observation-Carried-Forward (LOCF).