Status:
ACTIVE_NOT_RECRUITING
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
Lead Sponsor:
Mclean Hospital
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The protocol involves functional Magnetic Resonance Imaging acquisitions immediately before and after Low Field Magnetic Stimulation treatment on two separate days in a sham controlled, randomized tri...
Detailed Description
In this study, the investigators will examine changes in brain activity from Low Field Magnetic Stimulation in subjects over the age of 50 with bipolar disorder who are currently depressed using funct...
Eligibility Criteria
Inclusion
- Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
- Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
- Subjects must be capable of providing informed consent.
- Subjects must permanently reside within a 2-hour drive of McLean Hospital.
- Subjects must be currently seen by a provider (psychiatrist, therapist, PCP) whose practice is within a 2-hour drive of McLean Hospital.
Exclusion
- Dangerous or active suicidal ideation, as measured by the C-SSRS (see "Safety Measures" section), and physician evaluation.
- Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia.
- Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening.
- Subject has an MMSE score ≤ 24.
- Subject is pregnant or plans on becoming pregnant.
- Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
- 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).
- Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 21 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03484494
Start Date
May 29 2018
End Date
May 21 2025
Last Update
July 29 2024
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478