An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-12-13.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.
This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR*D study.
The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 2 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.
Change in Hamilton Rating Scale for Depression (HRS-D17)
The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)
The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16. Screening test scoring ranges: * 0-5, No Depression Likely * 6-10, Possibly Mildly Depressed * 11-15, Moderate Depression * 16-20, Severe Depression * 21 or Over, Very Severe Depression
Time frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks
| Milestone | Repetitive Transcranial Magnetic Stimulation |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
No measurements were reported for this outcome.
The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16. Screening test scoring ranges: * 0-5, No Depression Likely * 6-10, Possibly Mildly Depressed * 11-15, Moderate Depression * 16-20, Severe Depression * 21 or Over, Very Severe Depression
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Repetitive Transcranial Magnetic Stimulation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Repetitive Transcranial Magnetic Stimulation |
|---|---|
| Female | 1 |
| Male | 1 |
| Region of Enrollment(participants) | Repetitive Transcranial Magnetic Stimulation |
|---|---|
| United States | 2 |
This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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