NCT00578383

Brief Summary

This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 30, 2014

Completed
Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

December 18, 2007

Results QC Date

October 9, 2013

Last Update Submit

April 12, 2016

Conditions

DepressionBipolar DepressionMajor Depressive Disorder

Keywords

DepressionMajor depressionBipolar DisorderBipolar depressionLFMSlow field magnetic stimulationmood disordersaffective disorders

Outcome Measures

Primary Outcomes (4)

  • Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression

    A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.

    Once just before and once just after treatment

  • Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder

    A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.

    Once just before and once just after treatment

  • Visual Analog Scale (VAS) in Subjects With Bipolar Depression

    Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.

    Once just before and once just after treatment

  • Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder

    Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.

    Once just before and once just after treatment

Secondary Outcomes (8)

  • Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.

    Once just before and once just after treatment

  • Visual Analog Scale (VAS): Combined Diagnostic Groups.

    Once just before and once just after treatment

  • Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.

    Once just before and once just after treatment

  • Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.

    once pre and once post LFMS treatment

  • Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.

    Once just before and once just after treatment

  • +3 more secondary outcomes

Study Arms (4)

Sham (inactive) Treatment BPD

SHAM COMPARATOR

20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects

Device: Low Field Magnetic Stimulation Device

Active LFMS treatment in BPD

ACTIVE COMPARATOR

20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects

Device: Low Field Magnetic Stimulation Device

Sham LFMS Comparator: in MD

SHAM COMPARATOR

20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects

Device: Low Field Magnetic Stimulation Device

Experimental LFMS: in MD

ACTIVE COMPARATOR

20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects

Device: Low Field Magnetic Stimulation Device

Interventions

Low Field Magnetic Stimulation DeviceDEVICE

The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.

Also known as: LFMS
Active LFMS treatment in BPDExperimental LFMS: in MDSham (inactive) Treatment BPDSham LFMS Comparator: in MD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
  • May be medicated or unmedicated

You may not qualify if:

  • Contraindication for MRI due to metal in eyes/head
  • Claustrophobia.
  • Inability to lie flat.
  • History of brain injury.
  • Pregnant
  • Current drug use/abuse/dependence
  • History of polysubstance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (3)

  • 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: 15780843BACKGROUND

  • 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: 14702256BACKGROUND

  • Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.

    PMID: 24331545DERIVED

Related Links

MeSH Terms

Conditions

DepressionBipolar DisorderDepressive Disorder, MajorMood Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMental DisordersDepressive Disorder

Limitations and Caveats

A limitation of the current trial was that it was underpowered to detect moderate but clinically significant benefits of LFMS in diagnostic subgroups.

Results Point of Contact

Title
Dr. Michael Rohan
Organization
McLean Hospital
mrohan@mclean.harvard.edu
617-855-3127

Study Officials

  • Michael Rohan, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Imaging Physicist

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 21, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2013

Last Updated

May 16, 2016

Results First Posted

April 30, 2014

Record last verified: 2016-04

Locations

US(1)