An interventional study of Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. in Mood Disorder, Bipolar Disorder and Major Depression, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by University of California, Davis · Not applicable, Interventional, and Device feasibility
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 15 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim
Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
High frequency repetitive TMS given daily on weekdays for 3 weeks
Also known as: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Time frame: 5 weeks
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.
Time frame: 5 weeks
| Milestone | Experimental |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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.
| units on a scale | Experimental |
|---|---|
| Week 1 | 18.4 ± 8.7 |
| Week 2 | 13.4 ± 6.8 |
| Week 3 | 12.4 ± 6.8 |
| Week 5 | 13.7 ± 7.4 |
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.
| units on a scale | Experimental |
|---|---|
| Week 1 | 41.1 ± 10.2 |
| Week 2 | 34.3 ± 15.5 |
| Week 3 | 30.5 ± 16.1 |
| Week 5 | 31.9 ± 15.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rTMS Treatment | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Event | rTMS Treatment |
|---|---|
| Mild Focal PainSkin and subcutaneous tissue disorders | 3/15 |
| Age, Categorical(Participants) | Experimental |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 12 |
| Age, Continuous(years) | Experimental |
|---|---|
| Mean | 50 (19 to 68) |
| Sex: Female, Male(Participants) | Experimental |
|---|---|
| Female | 10 |
| Male | 5 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of California, Davis