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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03484494
Eligibility Criteria:
Inclusion Criteria:
1. Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
2. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
3. Subjects must be capable of providing informed consent.
4. Subjects must permanently reside within a 2-hour drive of McLean Hospital.
5. Subjects must be currently seen by a provider (psychiatrist, therapist, PCP) whose practice is within a 2-hour drive of McLean Hospital.
Exclusion Criteria:
1. Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation.
2. Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia.
3. Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening.
4. Subject has an MMSE score ≤ 24.
5. Subject is pregnant or plans on becoming pregnant.
6. Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
7. Subject has recent history of substance abuse (cannot meet DSM-5 criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).
8. Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03484494
Study Brief:
Protocol Section:
NCT03484494