Clinical trial NCT00578383: Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
Official title: Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Bipolar Depression
Major Depressive Disorder
Keywords: Depression
Major depression
Bipolar Disorder
Bipolar depression
LFMS
low field magnetic stimulation
mood disorders
affective disorders
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2007-12-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
timeFrame: Once just before and once just after treatment
measure: Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
timeFrame: Once just before and once just after treatment
measure: Visual Analog Scale (VAS) in Subjects With Bipolar Depression
timeFrame: Once just before and once just after treatment
measure: Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
timeFrame: Once just before and once just after treatment
Secondary outcomes:
measure: Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
timeFrame: Once just before and once just after treatment
measure: Visual Analog Scale (VAS): Combined Diagnostic Groups.
timeFrame: Once just before and once just after treatment
measure: Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
timeFrame: Once just before and once just after treatment
measure: Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
timeFrame: once pre and once post LFMS treatment
measure: Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
timeFrame: Once just before and once just after treatment
measure: Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
timeFrame: Once just before and once just after treatment
measure: Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
timeFrame: once pre and once post LFMS treatment
measure: Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
timeFrame: once pre and once post LFMS treatment
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Michael Rohan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.