Bipolar Depression, Depression, Major Depressive Disorder
Conditions
Keywords
Depression, Major depression, Bipolar Disorder, Bipolar depression, LFMS, low field magnetic stimulation, mood disorders, affective disorders
Brief summary
This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.
Detailed description
This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a non-significant risk device by the FDA, and there are no known risks associated with its use.
Interventions
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.
Sponsors
Stanley Medical Research Institute
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed * May be medicated or unmedicated
Exclusion criteria
* Contraindication for MRI due to metal in eyes/head * Claustrophobia. * Inability to lie flat. * History of brain injury. * Pregnant * Current drug use/abuse/dependence * History of polysubstance use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression | Once just before and once just after treatment | A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression. |
| Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder | Once just before and once just after treatment | A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression. |
| Visual Analog Scale (VAS) in Subjects With Bipolar Depression | Once just before and once just after treatment | Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been. |
| Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder | Once just before and once just after treatment | Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression. | Once just before and once just after treatment | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. |
| Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder | Once just before and once just after treatment | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. |
| Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups. | Once just before and once just after treatment | A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression. |
| Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder | once pre and once post LFMS treatment | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. |
| Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression | once pre and once post LFMS treatment | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. |
| Visual Analog Scale (VAS): Combined Diagnostic Groups. | Once just before and once just after treatment | Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been. |
| Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group. | Once just before and once just after treatment | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. |
| Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group. | once pre and once post LFMS treatment | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. |
Countries
United States
Participant flow
Recruitment details
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
Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.
Participants by arm
| Arm | Count |
|---|---|
| Bipolar Disorder Active LFMS Treatment Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device. | 37 |
| 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. | 36 |
| Major Depressive Disorder Active LFMS Treatment Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device. | 19 |
| 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. | 15 |
| Total | 107 |
Baseline characteristics
| Characteristic | Bipolar Disorder Sham LFMS Treatment | Major Depressive Disorder Active LFMS Treatment | Bipolar Disorder Active LFMS Treatment | Major Depressive Disorder Sham LFMS Treatment | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 19 Participants | 36 Participants | 15 Participants | 106 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 12.2 | 43.1 years STANDARD_DEVIATION 15.5 | 42.6 years STANDARD_DEVIATION 13 | 43.5 years STANDARD_DEVIATION 14.9 | 42.9 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 36 participants | 19 participants | 37 participants | 15 participants | 107 participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 25 Participants | 8 Participants | 60 Participants |
| Sex: Female, Male Male | 21 Participants | 7 Participants | 12 Participants | 7 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 2 / 36 | 0 / 19 | 0 / 15 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 | 0 / 19 | 0 / 15 |
Outcome results
Primary
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder | -7.19 units on a scale | Standard Error 1.44 |
| Combined Group Sham LFMS Treatment | Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder | -4.02 units on a scale | Standard Error 1.54 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.p-value: 0.1995% CI: [-3.3, 9.6]Regression, Linear
Primary
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression | -8.3 units on a scale | Standard Error 1 |
| Combined Group Sham LFMS Treatment | Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression | -5.79 units on a scale | Standard Error 1.07 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.p-value: 0.0995% CI: [-1.2, 6.2]Regression, Linear
Primary
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Visual Analog Scale (VAS) in Subjects With Bipolar Depression | -1.18 units on a scale | Standard Error 0.37 |
| Combined Group Sham LFMS Treatment | Visual Analog Scale (VAS) in Subjects With Bipolar Depression | -1.05 units on a scale | Standard Error 0.35 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.p-value: 0.1595% CI: [-0.6, 2.1]Regression, Linear
Primary
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder | -1.33 units on a scale | Standard Error 0.53 |
| Combined Group Sham LFMS Treatment | Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder | 0.25 units on a scale | Standard Error 0.25 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.p-value: 0.0495% CI: [-0.4, 3.6]Regression, Linear
Secondary
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups. | -8.13 units on a scale | Standard Error 0.87 |
| Combined Group Sham LFMS Treatment | Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups. | -5.02 units on a scale | Standard Error 0.78 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.p-value: 0.00995% CI: [0.5, 5.8]Regression, Linear
Secondary
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Time frame: once pre and once post LFMS treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group. | -7.00 units on a scale | Standard Error 1.02 |
| Combined Group Sham LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group. | -5.00 units on a scale | Standard Error 0.91 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)p-value: 0.1595% CI: [-1.1, 5.1]Regression, Linear
Secondary
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Time frame: once pre and once post LFMS treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression | -7.66 units on a scale | Standard Error 1.45 |
| Combined Group Sham LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression | -6.31 units on a scale | Standard Error 1.39 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)p-value: 0.5295% CI: [-4.1, 6.8]Regression, Linear
Secondary
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Time frame: once pre and once post LFMS treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder | -5.28 units on a scale | Standard Error 1.1 |
| Combined Group Sham LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder | -3.04 units on a scale | Standard Error 0.63 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)p-value: 0.195% CI: [-1.3, 5.8]Regression, Linear
Secondary
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group. | 3.16 units on a scale | Standard Error 0.93 |
| Combined Group Sham LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group. | -0.94 units on a scale | Standard Error 0.79 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).p-value: 0.00195% CI: [1.3, 6.9]Regression, Linear
Secondary
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression. | 4.18 units on a scale | Standard Error 1.37 |
| Combined Group Sham LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression. | -0.79 units on a scale | Standard Error 0.93 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)p-value: 0.00495% CI: [0.8, 9.2]Regression, Linear
Secondary
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder | 1.05 units on a scale | Standard Error 1.07 |
| Combined Group Sham LFMS Treatment | Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder | -0.63 units on a scale | Standard Error 1.11 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)p-value: 0.395% CI: [1.3, 5.8]Regression, Linear
Secondary
Visual Analog Scale (VAS): Combined Diagnostic Groups.
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Time frame: Once just before and once just after treatment
Population: Qualifying subjects who completed the the study with qualifying HAM-D scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Group Active LFMS Treatment | Visual Analog Scale (VAS): Combined Diagnostic Groups. | -1.66 units on a scale | Standard Error 0.29 |
| Combined Group Sham LFMS Treatment | Visual Analog Scale (VAS): Combined Diagnostic Groups. | -0.60 units on a scale | Standard Error 0.23 |
Comparison: Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.p-value: 0.00695% CI: [0.2, 1.9]Regression, Linear