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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT05685758
Eligibility Criteria:
Inclusion Criteria:
* Consenting Adults, ages 20-50
* Able to read, understand and provide written informed consent in English
* Participants who are the sole users of an iPhone or an Android smartphone, and agree to download and use the digital mobile phone application as required by the protocol
* Participants who are comfortable using applications and games on their smartphones
* Participants with a current primary diagnosis of MDD or mild depression. MADRSā„15 and \<35
* Participants who are taking any medications which are FDA approved or used off-label for mood or anxiety should be on a stable dosage for the past 6 weeks and have no plan to change dosage during the 8 weeks they will be in the study
* Participants who are receiving therapy should have been with the same therapist for the previous 60 days and have no plan to change therapy protocol during the 8 weeks of the study
Exclusion Criteria:
* Participants who have plans to change their medications which are FDA approved or used off-label for mood or anxiety or their therapy protocol during the 8 weeks of the study
* Participants who have made any changes to their therapy protocol, including starting therapy, stopping therapy, or changing providers within the past 60 days
* Participants who have made any changes to medications which are FDA-approved or used off-label for mood or anxiety in the last 6 weeks
* Participants who have used a computer, web, or smartphone software-based application for mental health or depression in the last 6 weeks
* Being at imminent risk for Suicidal behavior (via MINI)
Note: Other protocol-defined exclusion criteria applied.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT05685758
Study Brief:
Protocol Section:
NCT05685758