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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.
Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS treatment | Experimental | Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. | Device | High frequency repetitive TMS given daily on weekdays for 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D) | Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inventory of Depressive Symptomatology | Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guohua Xia, M.D., Ph.D. | Department of Psychiatry and Behavioral Sciences, UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Mind and Brain | Davis | California | 95618 | United States |
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| Label | URL |
|---|---|
| PI facilitation | View source |
| Trial Location: Center for Mind and Brain | View source |
| Dr. Xia's blog briefly introducing the trial |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression (HAM-D) | Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
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| Secondary | Inventory of Depressive Symptomatology | Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
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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 | rTMS Treatment | Active rTMS treatment Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks | 0 | 15 | 0 | 15 | 3 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Focal Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Discomfort to mild pain in skin area where simulation was applied |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guohua Xia | UC Davis | 916-734-3574 | gxia@ucdavis.edu |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D003866 | Depressive Disorder |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Title | Measurements |
|---|---|
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| Week 5 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Week 2 |
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| Week 3 |
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| Week 5 |
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