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Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00578383
First received: December 18, 2007
Last updated: March 28, 2014
Last verified: March 2014
History of Changes
Results First Received: October 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Bipolar Depression
Major Depressive Disorder
Intervention: Device: Low Field Magnetic Stimulation Device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from March 2008 though February 2011. They were recruited through flyers distributed around McLean Hospital (Belmont, MA), referral by clinic doctors and direct recruitment on the hospital's units.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.

Reporting Groups
  Description
Bipolar Disorder Active LFMS Treatment Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
Bipolar Disorder Sham LFMS Treatment Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
Major Depressive Disorder Active LFMS Treatment Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
Major Depressive Disorder Sham LFMS Treatment Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.

Participant Flow:   Overall Study
    Bipolar Disorder Active LFMS Treatment     Bipolar Disorder Sham LFMS Treatment     Major Depressive Disorder Active LFMS Treatment     Major Depressive Disorder Sham LFMS Treatment  
STARTED     37     36     19     15  
COMPLETED     21     20     13     9  
NOT COMPLETED     16     16     6     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.

Reporting Groups
  Description
Bipolar Disorder Active LFMS Treatment Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
Bipolar Disorder Sham LFMS Treatment Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
Major Depressive Disorder Active LFMS Treatment Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
Major Depressive Disorder Sham LFMS Treatment Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
Total Total of all reporting groups

Baseline Measures
    Bipolar Disorder Active LFMS Treatment     Bipolar Disorder Sham LFMS Treatment     Major Depressive Disorder Active LFMS Treatment     Major Depressive Disorder Sham LFMS Treatment     Total  
Number of Participants  
[units: participants]
 		  37     36     19     15     107  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     36     36     19     15     106  
>=65 years     1     0     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation 		  42.6  ± 13.0     42.2  ± 12.2     43.1  ± 15.5     43.5  ± 14.9     42.9  ± 13.3  
Gender  
[units: participants]
 		         
Female     25     15     12     8     60  
Male     12     21     7     7     47  
Region of Enrollment  
[units: participants]
 		         
United States     37     36     19     15     107  



  Outcome Measures
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1.  Primary:   Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 1

2.  Primary:   Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 2

3.  Primary:   Visual Analog Scale (VAS) in Subjects With Bipolar Depression   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 3

4.  Primary:   Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 5

6.  Secondary:   Visual Analog Scale (VAS): Combined Diagnostic Groups.   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 6

7.  Secondary:   Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 7

8.  Secondary:   Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.   [ Time Frame: once pre and once post LFMS treatment ]
  Show Outcome Measure 8

9.  Secondary:   Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 9

10.  Secondary:   Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder   [ Time Frame: Once just before and once just after treatment ]
  Show Outcome Measure 10

11.  Secondary:   Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression   [ Time Frame: once pre and once post LFMS treatment ]
  Show Outcome Measure 11

12.  Secondary:   Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder   [ Time Frame: once pre and once post LFMS treatment ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A limitation of the current trial was that it was underpowered to detect moderate but clinically significant benefits of LFMS in diagnostic subgroups.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Rinah Yamamoto
Organization: McLean Hospital
phone: 617-855-2861
e-mail: yamamoto@mclean.harvard.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00578383     History of Changes
Other Study ID Numbers: 2006-P-001655, Stanley Grant 07TGS-1045
Study First Received: December 18, 2007
Results First Received: October 9, 2013
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration