Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder

In brief

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 trial, in order to assess the physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric population with bipolar depression.

Key facts

Study ID

NCT03484494

Run by

Mclean Hospital

People needed

40

Starts

2018-05-29

Expected to finish

2026-07-21

Last updated by the study team

2026-03-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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