Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

LFMS: Initial Trial in Geriatric Bipolar Depression (LFMS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2016 by Brent Forester, Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT02707276
First received: March 4, 2016
Last updated: April 14, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Bipolar Depression Depressed Phase
Device: Active Low Field Magnetic Stimulation
Device: Sham Low Field Magnetic Stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Field Magnetic Stimulation: Initial Trial in Geriatric Bipolar Depression

Further study details as provided by Brent Forester, Mclean Hospital:

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

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


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

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


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


Estimated Enrollment: 30
Study Start Date: June 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active LFMS
Active Low Field Magnetic Stimulation three 20 minute treatments, once per day for three 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 three 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

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 three treatments on consecutive days with one follow-up visit; this is a crossover study in which the treatments and follow-up are repeated after a one-week washout with the alternate (active, sham).

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.

  Eligibility

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02707276

Contacts
Contact: Joanna Georgakas 617.855.2410 JGEORGAKAS@PARTNERS.ORG
Contact: Michael L Rohan, Ph.D. 617.855.3127 mrohan@mclean.harvard.edu

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

Responsible Party: Brent Forester, Clinical Director, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02707276     History of Changes
Other Study ID Numbers: 2015P001851
Study First Received: March 4, 2016
Last Updated: April 14, 2016
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on May 25, 2017