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| ID | Type | Description | Link |
|---|---|---|---|
| Stanley Grant 07TGS-1045 | Other Grant/Funding Number | Stanley Grant 07TGS-1045 |
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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham (inactive) Treatment BPD | Sham Comparator | 20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects |
|
| Active LFMS treatment in BPD | Active Comparator | 20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects |
|
| Sham LFMS Comparator: in MD | Sham Comparator | 20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects |
|
| Experimental LFMS: in MD | Active Comparator | 20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Field Magnetic Stimulation Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Once just before and once just after treatment |
| 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. | Once just before and once just after treatment |
| 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. | Once just before and once just after treatment |
| 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. | Once just before and once just after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rohan, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15780843 | Background | 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. | |
| 14702256 | Background |
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Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bipolar Disorder Active LFMS Treatment | Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device. |
| FG001 | 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. |
| FG002 | Major Depressive Disorder Active LFMS Treatment | Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bipolar Disorder Active LFMS Treatment | Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device. |
| BG001 | Bipolar Disorder Sham LFMS Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
2 years, 10 months
participant self report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bipolar Disorder Active LFMS Treatment | Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness at venepuncture | General disorders | Non-systematic Assessment | dizziness at the sight of blood - psychological |
A limitation of the current trial was that it was underpowered to detect moderate but clinically significant benefits of LFMS in diagnostic subgroups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Rohan | McLean Hospital | 617-855-3127 | mrohan@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
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|
|
| Once just before and once just after treatment |
| 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. | Once just before and once just after treatment |
| 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. | Once just before and once just after treatment |
| 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. | once pre and once post LFMS treatment |
| 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. | Once just before and once just after treatment |
| 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. | Once just before and once just after treatment |
| 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. | once pre and once post LFMS treatment |
| 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. | once pre and once post LFMS treatment |
| 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. doi: 10.1176/appi.ajp.161.1.93. |
| 24331545 | Derived | Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12. |
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.
| BG002 | Major Depressive Disorder Active LFMS Treatment | Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Combined Group Sham LFMS Treatment | Combined diagnostic groups 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. |
|
|
|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
|
|
|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
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|
|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores. | Posted | Mean | Standard Error | units on a scale | once pre and once post LFMS treatment |
|
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|
|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
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|
|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
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|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
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|
|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
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|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
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| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | Once just before and once just after treatment |
|
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|
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| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | once pre and once post LFMS treatment |
|
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|
| 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. | Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data. | Posted | Mean | Standard Error | units on a scale | once pre and once post LFMS treatment |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | 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. | 0 | 36 | 2 | 36 |
| EG002 | Major Depressive Disorder Active LFMS Treatment | Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device. | 0 | 19 | 0 | 19 |
| EG003 | 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. | 0 | 15 | 0 | 15 |
|
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| D003866 |
| Depressive Disorder |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| Superiority or Other |
| No |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |