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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT05810259
Eligibility Criteria:
Inclusion Criteria:
* Resides in United States
Exclusion Criteria:
* Any individual who endorses any of the following criteria will be excluded from participation in this study:
* Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ):
* Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia.
* Positive Psychiatric Disorders Screening Questions:
* Positive screen for depression, excluding suicide (PHQ-8) cutoff score \> 6
* Positive screen for panic (SMPD) cutoff score \> 2
* Positive screen for generalized anxiety (GAD-7) cutoff score \> 10
* Positive screen psychosis (PDSQ) via psychosis section, cutoff score \> 3
* Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score \> 6
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05810259
Study Brief:
Protocol Section:
NCT05810259