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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT05223959
Eligibility Criteria:
Inclusion Criteria:
* Adult outpatients age 18 and above
* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) bipolar disorder (both BD I and BD II), currently in remission, confirmed by Structured Clinical Interview for DSM-5 (SCID)
* Currently euthymic (Hamilton Depression Rating Scale, HDRS-17 \< 8 and Young Mania Rating Scale, YMRS \<8)
* Able to give written informed consent
* On stable psychiatric medication regimen for at least 3 months
* Resident of the trial catchment area.
Exclusion Criteria:
* Active substance use disorder, based on DSM-5 criteria
* Currently experiencing recurrence (mania, hypomania, mixed or depressive
* Active suicidal ideation
* Unstable residential arrangements that reduce likelihood of being available for the duration of trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05223959
Study Brief:
Protocol Section:
NCT05223959