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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00217217
Other study ID # 2004P-002631
Secondary ID
Status Terminated
Phase Phase 3
First received September 15, 2005
Last updated March 13, 2012
Start date September 2004
Est. completion date January 2012

Study information

Verified date March 2012
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Device:
Echo-Planar Magnetic Resonance Imaging (EP-MRSI)
variable-setting low-frequency MRI

Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Mclean Hospital Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Positive and Negative Affect Scale pre/post-treatment
Secondary Visual-Analog Scales pre/post-treatment
Secondary Montgomery Asberg Depression Rating Scale (MADRS) pre-treatment
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