A Phase 3 interventional study of Echo-Planar Magnetic Resonance Imaging (EP-MRSI) in Bipolar Depression, Bipolar Disorder and Depression, sponsored by Mclean Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-14.
Sponsored by Mclean Hospital · Phase 3, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 13 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)
Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).
Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
variable-setting low-frequency MRI
Also known as: Low Field Magnetic Stimulation (LFMS)
Positive and Negative Affect Scale
Time frame: pre/post-treatment
Visual-Analog Scales
Time frame: pre/post-treatment
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: pre-treatment
This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Mclean Hospital