Clinical trial NCT00217217: Low Field Magnetic Stimulation Treatment for Bipolar Depression
Official title: Low Field Magnetic Stimulation in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Depression
Bipolar Disorder
Depression
Keywords: non-pharmaceutical
alternative
imaging
magnetic resonance imaging
low field magnetic stimulation
bipolar disorder
depression
bipolar depression
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2005-09-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.

Detailed description: An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of bipolar disorder.
* Current depression.

Exclusion Criteria:

* Contraindication for MRI due to metal in eyes/head
* Claustrophobia.
* Inability to lie flat.
* History of brain injury.

Primary outcomes:
measure: Positive and Negative Affect Scale
timeFrame: pre/post-treatment
Secondary outcomes:
measure: Visual-Analog Scales
timeFrame: pre/post-treatment
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: pre-treatment
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Michael Rohan, MS
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.