Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT05548595
Eligibility Criteria:
Inclusion Criteria:
1. Middle, high school, or college students who are 12 to 18 years of age (inclusive).
2. In good general health (no active or uncontrolled diseases, infections, or conditions) and able to swallow the study products (tablets).
3. Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening.
4. Individuals of childbearing potential must practice a medically acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
1. use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System); or
2. use for at least 1 month prior to the first dose of study product: double-barrier method, intrauterine devices or
3. vasectomy of partner at least 6 months prior to the first dose of study product Individuals of the potential to get others pregnant must use condoms or other medically acceptable methods to prevent pregnancy throughout the study.
5. Agree to refrain from treatments listed in protocol in the defined timeframe.
6. Participant and participant's legally authorized representative (LAR, if applicable) are willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent and assent, be able to understand and perform the assessments, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow evaluations related to cognitive function.
Exclusion Criteria:
1. Female or transgendered male participants who are lactating, pregnant or planning to become pregnant during the study.
2. History of diagnosis of depression, other psychiatric disorders (e.g., attention deficit hyperactivity disorder \[ADHD\]), or any related condition within the past five years.
3. History of heart disease/cardiovascular disease, uncontrolled hypertension (i.e., ≥130 mmHg systolic and/or ≥80 mmHg diastolic), kidney disease (dialysis or renal failure), hepatic impairment, Type I or Type II diabetes, unstable thyroid disease, immune disorder (i.e., HIV/AIDS), or cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
4. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
5. Use of concomitant treatments listed in protocol within the defined timeframe.
6. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
7. History of alcohol or substance abuse in the 12 months prior to screening.
8. Receipt or use of test product(s) in another research study within 28 days prior to baseline (Visit 2) or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
9. Siblings or family members living at the same address if there is already a participant from the same family/address.
10. Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05548595
Study Brief:
Protocol Section:
NCT05548595