Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression



Status:Recruiting
Conditions:Depression, Depression, Psychiatric, Bipolar Disorder, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:8/18/2018
Start Date:May 29, 2018
End Date:March 2021
Contact:Hannah L Heintz, BA
Email:hheintz@mclean.harvard.edu
Phone:617-855-3225

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The protocol involves functional Magnetic Resonance Imaging and Magnetic Resonance
Spectroscopy 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.

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 functional Magnetic Resonance Imaging and proton Magnetic Resonance
Spectroscopy. Following screening visits, study procedures include two visits, at least two
weeks apart, during which subjects will complete brief mood scales, undergo 15 minutes of
imaging, receive 20 minutes of Low Field Magnetic Stimulation treatment, and then return to
the scanner to undergo another 15 minutes of imaging procedures. Due to the crossover design,
subjects receiving active treatment during the first visit will receive sham treatment during
the second visit; subjects receiving sham treatment during the first visit will receive
active treatment during the second visit. A follow-up phone call will occur two days after
each imaging/treatment visit. The main endpoint of this study is the observation of changes
in resting state functional Magnetic Resonance Imaging activity in post-treatment
acquisitions as compared to pre-treatment acquisitions.

Inclusion Criteria:

- Diagnosis of Bipolar Disorder Type I or II, current episode depressed as measured by a
Montgomery-Asberg Depression Rating Scale score of 20 or above at screening.

- Maintained on a stable dose of all psychotropic medications for a period of at least
two weeks prior to screening.

- Capable of providing informed consent.

Exclusion Criteria:

- Dangerous or active suicidal ideation, as measured by the Columbia-Suicide Severity
Rating Scale and physician evaluation.

- Meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for any Axis I disorder
other than Bipolar Disorder or an anxiety disorder (e.g. Major Depressive Disorder,
dementia).

- Current mania as defined by a score of 10 or above on the Young Mania Rating Scale
(YMRS) at screening.

- Score of 24 or lower on the Mini-Mental State Exam.

- Subject is pregnant or plans on becoming pregnant.

- Subject has recent history (within 7 days of screening) of Electroconvulsive Therapy
or Transcranial Magnetic Stimulation.

- 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 Magnetic Resonance Imaging (i.e. presence of a
pacemaker, neurostimulator, or metal in head or neck).
We found this trial at
1
site
115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
Principal Investigator: Brent P Forester, MD
Phone: 617-855-3622
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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from
Belmont, MA
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