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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04496505
Eligibility Criteria:
Inclusion Criteria:
* 1\. Willingly provides written informed consent prior to the conduct of any study-related procedures.
2\. Male or female, 18 to 65 years of age, inclusive. 3. Clinical diagnosis of Major Depressive Disorder. 4. Patient must be in generally good health based upon the results of a medical history, physical examination, and vital signs, at the investigator's discretion.
5\. Willing and able to comply with the study requirements, complete study assessments, and visit the clinic at the scheduled times for the duration of the Treatment Phase.
6\. Able to understand, speak and read English sufficient for the completion of study assessments.
Exclusion Criteria:
1. Pregnant (verbal patient report only) or lactating.
2. History or presence of photo-sensitive epilepsy or other photo-sensitive conditions.
3. History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo
4. History or presence of migraine, at the investigator's discretion
5. Vision impairments that affect perception of light, color, or brightness in one or both eyes, or differences in visual perception between eyes.
6. Deafness in one or both ears, perceived differences in hearing between ears or tinnitus.
7. Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion).
8. Presence of inflammation or broken skin around the eyes in the area of the mask.
9. Participating in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days.
10. Any pending legal action that could prohibit participation or compliance in the study.
11. Any psychiatric diagnosis that would preclude competency to consent to participation.
12. Significant medical conditions or other circumstances which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.
13. Employee of the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or a family member of an employee or of the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04496505
Study Brief:
Protocol Section:
NCT04496505