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New treatment option for Anxiety Disorders
Official title Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
ClinicalTrials.gov ID: NCT04221997
What this study is testing
What is sertraline?
sertraline is an investigational medicine, being studied as a potential treatment for anxiety disorders.
Also referred to as Zoloft.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- for Patients with Anxiety Disorders and Healthy Comparison:
- people Co-occurring DSM-5 diagnosis mood (except persistent depressive disorder, unspecified depressive disorder or co- occurring anxiety 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...
- 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.
See the full eligibility 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. 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.
- for Patients with Anxiety Disorders and Healthy Comparison:
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.