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This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. In particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated theta burst treatment | Experimental | All participants will receive theta-burst TMS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent theta-burst stimulation (iTBS) delivered to the L-DLPFC | Device | Participants will receive iTBS to the left DLPFC and will be targeted utilizing either Localite's neuronavigation system or Nexstim's eField neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC or bilateral DLPFC using either a MagVenture MagPro X100 or a Nexstim TMS device. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale 21-Item Score | A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression. | Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Rating Scale for Depression (HAMD-17) | The HAMD-17 is a 17-item rating scale questionnaire administered by clinicians to rate a patient's level of depression . The total scores range from 0 to 52 with higher scores indicating worse depression. | Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Sahlem, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20439832 | Background | 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. | |
| 8547583 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Accelerated Theta Burst Treatment - Left DLPFC | Participants receive intermittent theta-burst stimulation (iTBS) to the left DLPFC 1,800 pulses per session. |
| FG001 | Accelerated Theta Burst Treatment - Bilateral DLPFC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2024 | Dec 5, 2025 |
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| Intermittent theta-burst stimulation (iTBS) delivered to the bilateral DLPFC | Device | Participants will receive iTBS to bilateral DLPFC. The DLPFC will be targeted utilizing either Localite's neuronavigation system or Nexstim's eField neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC or bilateral DLPFC using either a MagVenture MagPro X100 or a Nexstim TMS device. |
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| Change in The Scale for Suicide Ideation | A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. The total scores range from 0 to 38 with higher scores indicating greater suicidality. | Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment |
| Change in Hamilton Rating Scale for Depression (HAMD-6) | The HAMD-6 is a shorter, six-item version of the Hamilton Depression Rating Scale (HAMD-D) that measures core symptoms of major depressive disorder, such as depressed mood, guilt and anxiety. The total scores range from 0 to 22 with higher scores indicating worse depression. | Every day of stimulation on days (visits) 1, 2, 3, 4, and 5 |
| Change From Baseline Functional Connectivity | We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network. | Baseline, immediately post-treatment, 4 weeks post-treatment |
| Change in Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to measure the severity of depression symptoms. The total scores range from 0 to 63 with higher scores indicating worse depression. | Baseline, immediately post-treatment, 4 weeks post-treatment |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) | The MADRS (Montgomery-Åsberg Depression Rating Scale) is a 10-item diagnostic tool used by clinicians to assess the severity of depression by scoring symptoms on a 0-60 scale with higher scores indicating worse depression. | Baseline, immediate post-treatment, 4 weeks post-treatment |
| Background |
| George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008. |
| 8684201 | Background | Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6. |
| 26850210 | Background | Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3. |
| 25281475 | Background | Jelic MB, Milanovic SD, Filipovic SR. Differential effects of facilitatory and inhibitory theta burst stimulation of the primary motor cortex on motor learning. Clin Neurophysiol. 2015 May;126(5):1016-23. doi: 10.1016/j.clinph.2014.09.003. Epub 2014 Sep 16. |
| 25450537 | Background | Chung SW, Hoy KE, Fitzgerald PB. Theta-burst stimulation: a new form of TMS treatment for depression? Depress Anxiety. 2015 Mar;32(3):182-92. doi: 10.1002/da.22335. Epub 2014 Nov 28. |
Participants will receive bilateral iTBS (to the left DLPFC and right DLPFC), with option to dose escalate from 600 to 1800 pulses per session.
| Participants who dose-escalated |
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Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Accelerated Theta Burst Treatment - Left DLPFC | Participants receive iTBS to the left DLPFC 1,800 pulses per session. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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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 | ||||||||||||||||||||||
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| Primary | Change in Hamilton Depression Rating Scale 21-Item Score | A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5) |
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| Secondary | Change in Hamilton Rating Scale for Depression (HAMD-17) | The HAMD-17 is a 17-item rating scale questionnaire administered by clinicians to rate a patient's level of depression . The total scores range from 0 to 52 with higher scores indicating worse depression. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment |
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| Secondary | Change in The Scale for Suicide Ideation | A rating scale that measures the current intensity of specific attitudes, behaviors, and plans to commit suicide. The total scores range from 0 to 38 with higher scores indicating greater suicidality. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment |
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| Secondary | Change in Hamilton Rating Scale for Depression (HAMD-6) | The HAMD-6 is a shorter, six-item version of the Hamilton Depression Rating Scale (HAMD-D) that measures core symptoms of major depressive disorder, such as depressed mood, guilt and anxiety. The total scores range from 0 to 22 with higher scores indicating worse depression. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Every day of stimulation on days (visits) 1, 2, 3, 4, and 5 |
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| Secondary | Change From Baseline Functional Connectivity | We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network. | Not Posted | Baseline, immediately post-treatment, 4 weeks post-treatment | Participants | |||||||||||||||||||||||||||||||||
| Secondary | Change in Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to measure the severity of depression symptoms. The total scores range from 0 to 63 with higher scores indicating worse depression. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately post-treatment, 4 weeks post-treatment |
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| Secondary | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) | The MADRS (Montgomery-Åsberg Depression Rating Scale) is a 10-item diagnostic tool used by clinicians to assess the severity of depression by scoring symptoms on a 0-60 scale with higher scores indicating worse depression. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediate post-treatment, 4 weeks post-treatment |
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Up to 6 weeks (up to 1 week between baseline and first treatment session, 5 days treatment, plus an average of 4 weeks follow up)
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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 | Accelerated Theta Burst Treatment - Left DLPFC | Participants receive iTBS to the left DLPFC 1,800 pulses per session. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Protocol Director | Stanford University | 650-800-6920 | nbassano@stanford.edu |
| Prot_000.pdf |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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