NCT01557192

Brief Summary

To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

10 years

First QC Date

March 14, 2012

Last Update Submit

April 12, 2016

Conditions

Bipolar DepressionUnipolar Depression

Keywords

DepressionBipolar DepressionLFMSElectromagnetic Stimulation

Outcome Measures

Primary Outcomes (2)

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)score

    MADRS scores will be compared between the baseline and week 3, one week after the final treatment.

    at baseline and at week 3

  • Change in Positive-Negative Affect Scale (PANAS)score

    PANAS scores will be compared between the baseline and week 3, one week after the final treatment.

    at baseline and at one and at week 3

Secondary Outcomes (3)

  • Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings

    at baseline and immediately before and after each treatment, 6 treatments across 2 weeks

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)score

    at baseline and at week 4

  • Change in Positive-Negative Affect Scale (PANAS)score.

    at baseline and at one and at week 4

Study Arms (2)

Active LFMS treatment

ACTIVE COMPARATOR

20 minute exposure to the LFMS electromagnetic field treatment

Device: Low Field Magnetic Stimulation Device

Sham LFMS treatment

PLACEBO COMPARATOR

20 minute exposure to either the sham (inactive) electromagnetic field treatment

Device: Low Field Magnetic Stimulation Device

Interventions

Low Field Magnetic Stimulation DeviceDEVICE

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.

Also known as: LFMS
Active LFMS treatmentSham LFMS treatment

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects MUST be significantly depressed, currently.
  • Subjects must not have serious physical illnesses, neurological diseases or dementias.
  • Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
  • Subject must have a Ham-D score \> 17, YMRS score \< 7 (bipolar subjects only), and a MADRS score \> 18.
  • Subjects must be capable of providing informed consent.
  • Subjects must have an established residence and phone.
  • Subjects may be medicated or unmedicated.

You may not qualify if:

  • Dangerous or active suicidal ideation.
  • Pregnant or planning on becoming pregnant.
  • Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
  • Mixed mood state or rapid cycling.
  • Presence of a pacemaker, neurostimulator, or metal in head or neck.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

  • Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.

    PMID: 14702256RESULT

  • Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.

    PMID: 15780843RESULT

MeSH Terms

Conditions

Bipolar DisorderDepressive DisorderDepression

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Michael L. Rohan, Ph.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Imaging Physicist

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 19, 2012

Study Start

May 1, 2010

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

US(1)