Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device (LFMS)

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

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
Overall Participants Analyzed  [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

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 ]

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 ]

3.  Primary:

Visual Analog Scale (VAS) in Subjects With Bipolar Depression   [ Time Frame: Once just before and once just after treatment ]

4.  Primary:

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

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 ]

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

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 ]

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 ]

11.  Secondary:

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

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 ]

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.