Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH069887 | U.S. NIH Grant/Contract | View source | |
| DATR A5-ETMA | Other Identifier | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.
Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance.
The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active prefrontal rTMS phase1 | Experimental | Phase I participants receiving rTMS |
|
| Sham rTMS phase 1 | Placebo Comparator | Phase I participants receiving sham stimulation |
|
| rTMS extension | Experimental | rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS |
|
| Open label antidepressant regimen | Experimental | All patients who met remission who were then transitioned to medications after the TMS trial was completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prefrontal rTMS | Procedure | Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Remission, as Measured by the Hamilton Rating Scale for Depression | The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8 | Measured at the end of Phases 1, 2, and 3 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark S. George, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30329-5102 | United States | ||
| Columbia University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23769413 | Derived | Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21. | |
| 20439832 | Derived | George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46. |
Not provided
Not provided
Interested researchers can email the PI, Dr. George, with a request and how they plan to analyze the data. He will then make available a de-identified copy of the data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active TMS | Phase I participants receiving rTMS Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. |
| FG001 | Sham TMS | Phase I participants receiving sham stimulation Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. |
| FG002 | rTMS Extension | Phase II participants, all of whom did not meet remission requirements after phase 1. They will all receive active open label rTMS |
| FG003 | Open Label Antidepressant Regimen | All patients who met remission who were then transitioned to medications after the TMS trial was completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I |
| |||||||||||||
| Phase II |
| |||||||||||||
| Phase III |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active TMS | Phase I participants receiving rTMS Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Depression Remission, as Measured by the Hamilton Rating Scale for Depression | The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8 | Remission | Posted | Number | number of remitted patients | Measured at the end of Phases 1, 2, and 3 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TMS | Phase I participants receiving rTMS Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS): Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All adverse events | Psychiatric disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark S. George, MD, Professor | MUSC | 8438700368 | georgem@musc.edu |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Antidepressant Regimen | Drug | Particpants who acheive remission with rTMS may start antidepressant medication in phase III. |
|
|
| Sham Stimulation | Procedure | The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. |
|
| New York |
| New York |
| 10032 |
| United States |
| Brain Stimulation Laboratory, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Washington | Seattle | Washington | 98104-2499 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| Sham TMS |
Phase I participants receiving sham stimulation Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Phase I participants receiving sham stimulation Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. |
| OG002 | Active Open for 3 Weeks | Phase II participants Lower Dose rTMS: Participants who are unresponsive to Phase I treatment with rTMS will continue a lower dose of rTMS for an additional 3 to 7 weeks in Phase II. |
| OG003 | Medication Followup | Phase III participants Antidepressant Regimen: Particpants who acheive remission with rTMS may start antidepressant medication in phase III. |
|
|
| 0 |
| 92 |
| 18 |
| 92 |
| EG001 | Sham TMS | Phase I participants receiving sham stimulation Sham Stimulation: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. | 0 | 98 | 15 | 98 |
| EG002 | rTMS Extension | rTMS. Phase II participants, all of whom did not meet remission requirements after phase I. They all receive active open label rTMS | 0 | 144 | 0 | 144 |
| EG003 | Open Label Antidepressant Regimen | All patients who met remission who were then transitioned to medications after the TMS trial was completed | 0 | 61 | 0 | 61 |
Not provided
Not provided