Treatment Resistant Depression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntermittent theta-burst stimulation (iTBS) delivered to the L-DLPFC
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.
DEVICEIntermittent theta-burst stimulation (iTBS) delivered to the bilateral DLPFC
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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 75 years of age. * Able to provide informed consent. * Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE). * prior exposure to rTMS * Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method. * Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration. * Participants are required to have a stable psychiatrist for the duration of study enrollment.
Exclusion criteria
* History of MI, CABG, CHF, or other cardiac history * Any neurological conditions * History of epilepsy * OCD * Independent sleep disorder * Autism Spectrum Disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale 21-Item Score | Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Rating Scale for Depression (HAMD-17) | Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment | 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. |
| Change in The Scale for Suicide Ideation | Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment | 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. |
| Change in Hamilton Rating Scale for Depression (HAMD-6) | Every day of stimulation on days (visits) 1, 2, 3, 4, and 5 | 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. |
| Change From Baseline Functional Connectivity Within the Default Mode Network. | Baseline, immediately post-treatment, 4 weeks post-treatment | We will assess functional connectivity as seen on resting state fMRI within the default mode network. |
| Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network. | Baseline, immediately post-treatment, 4 weeks post-treatment | We will assess functional connectivity as seen on resting state fMRI of subcallosal cingulate cortex to the default mode network. |
| Change in Beck Depression Inventory (BDI) | Baseline, immediately post-treatment, 4 weeks post-treatment | 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. |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline, immediate post-treatment, 4 weeks post-treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory Sahlem, MD
Stanford University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 16.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed