LFMS: Initial Trial in Geriatric Bipolar Depression (LFMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02707276
Recruitment Status : Active, not recruiting
First Posted : March 14, 2016
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

Brief Summary:
The primary aim of this study is to assess the efficacy of Low Field Magnetic Stimulation (LFMS) in treating symptoms of depression and anxiety in older adults suffering from bipolar depression. The investigators also aim to assess any cognitive benefits from regular LFMS treatments in older adults suffering from bipolar depression.

Condition or disease Intervention/treatment Phase
Bipolar Depression Depressed Phase Device: Active Low Field Magnetic Stimulation Device: Sham Low Field Magnetic Stimulation Not Applicable

Detailed Description:

The investigators have previously observed mood improvement in participants with bipolar depression in a population aged 21-60. Here the investigators hope to extend these results to a similar but new population, geriatric bipolar depression (GPD). In addition to the evaluation of the effect of multiple treatments, as well as observation of the duration of the effect after a delay of one week in this population, the investigators will assess whether this population presents any noticeable difference in tolerance or effect.

The protocol involves five treatments on consecutive days with one follow-up visit; this is a randomized, double-blind, sham-controlled study (subjects will either receive active treatment or sham treatment for all five treatment sessions).

The mechanisms of depression in a geriatric population may differ from those in a younger population. In particular, brain structures and connectivity have changed, and there is the increased risk of comorbid diagnoses such as dementia that might confound treatment and assessment. In this study the investigators hope to extend the findings of LFMS in the general population to directly address the treatment of bipolar depression in a geriatric population.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Field Magnetic Stimulation: Initial Trial in Geriatric Bipolar Depression
Actual Study Start Date : September 7, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active LFMS
Active Low Field Magnetic Stimulation three 20 minute treatments, once per day for five consecutive days
Device: Active Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Other Name: Active LFMS

Sham Comparator: Sham LFMS
Sham Low Field Magnetic Stimulation three 20 minute treatments, once per day for five consecutive days
Device: Sham Low Field Magnetic Stimulation
The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
Other Name: Sham LFMS

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 week ]
    10 item interviewer rated assessment for depression

  2. Beck Depression Inventory (BDI) [ Time Frame: 30 minutes ]
    21 item self rating depression assessment

Secondary Outcome Measures :
  1. Hamilton Anxiety Rating Scale (HARS) [ Time Frame: 1 week ]
    14 item interviewer rated assessment of anxiety

  2. Beck Anxiety Inventory (BAI) [ Time Frame: 30 minutes ]
    21 item self rating anxiety assessment

Other Outcome Measures:
  1. CNS Vital Signs Cognitive Battery (CNSVS) [ Time Frame: 1 week ]
    Electronic multi-modular cognitive assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Subjects will be men or women aged 55 years or older.
  2. Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
  3. Subjects must have failed at least one FDA approved treatment for bipolar depression before enrolling in this study. Failed treatment is defined as 8 weeks of treatment at standard dose (Selective Serotonin Reuptake Inhibitors (SSRI) , Selective Norepinephrine Reuptake Inhibitors (SNRI), mood stabilizer, or typical or atypical antipsychotic).
  4. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
  5. Subjects must be capable of providing informed consent.

Exclusion criteria:

  1. Subjects meeting Diagnostic Statistical Manual-IV-TR (DSM-IV-TR) criteria for any Axis I disorder other than Bipolar Disorder or an anxiety disorder (eg. Major Depressive Disorder, dementia).
  2. Subject has an Mini Mental State Exam (MMSE) score ≤ 24.
  3. Subject is pregnant or plans on becoming pregnant.
  4. Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
  5. Subject has recent history of substance abuse (cannot meet DSM-IV-TR 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).
  6. Subject has any contraindication for Magnetic Resonance Imaging (MRI) (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02707276

United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Principal Investigator: Brent Forester, M.D. MSc. Mclean Hospital

Responsible Party: Brent Forester, Clinical Director, Mclean Hospital Identifier: NCT02707276     History of Changes
Other Study ID Numbers: 2015P001851
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brent Forester, Mclean Hospital:
Bipolar Depression
Low Field Magnetic Stimulation

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders