Study Stopped
Study was terminated for lack of recruitment.
Low Field Magnetic Stimulation Treatment for Bipolar Depression
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2004
Longer than P75 for phase_3
1 active site
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 14, 2012
March 1, 2012
7.3 years
September 15, 2005
March 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive and Negative Affect Scale
pre/post-treatment
Secondary Outcomes (2)
Visual-Analog Scales
pre/post-treatment
Montgomery Asberg Depression Rating Scale (MADRS)
pre-treatment
Study Arms (2)
Active EEP-MRSI treatment
EXPERIMENTAL20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI)
Sham comparator EP-MRSI
SHAM COMPARATORSham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI).
Interventions
variable-setting low-frequency MRI
Eligibility Criteria
You may qualify if:
- Primary diagnosis of bipolar disorder.
- Current depression.
You may not qualify if:
- Contraindication for MRI due to metal in eyes/head
- Claustrophobia.
- Inability to lie flat.
- History of brain injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Related 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. doi: 10.1016/j.biopsych.2004.12.011.
PMID: 15780843BACKGROUNDRohan 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: 14702256RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Rohan, MS
Mclean Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Imaging Physicist
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 22, 2005
Study Start
September 1, 2004
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
March 14, 2012
Record last verified: 2012-03