Clinical trial NCT04497350: Transcranial Magnetic Stimulation vs Theta Burst Stimulation in Major Depressive Disorder
Official title: A Blinded, Randomized Trial Comparing the Effects of Transcranial Magnetic Stimulation and Theta Burst Stimulation in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: transcranial magnetic stimulation
theta burst stimulation
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a single-site, randomized, blinded, clinical trial comparing the efficacy of transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) in subjects with treatment refractory depression (trMDD). The study will recruit 30 subjects, all suffering from treatment refractory depression (trMDD). Half of the subjects (15) will be randomized to the TMS treatment group, while the other half will be assigned to the iTBS treatment group. The randomization ratio will be 1:1.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the differences in efficacy between transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) treatment in subjects suffering from major depressive disorder.

Detailed description: Up to 30 patients of any gender aged from 18 to 70 years old will be recruited for inclusion once candidacy has been established by screening criteria.

Once recruited, patients will be randomly assigned to the TMS treatment group or the iTBS treatment group. Patients will be blinded to their group assignment, but will be informed of their assignment upon the final outcome measure collection timepoint (e.g., 1 month post-treatment). Patients who failed to respond by 1-month post iTBS or TMS treatment will be allowed to cross-over into the other treatment group and will be re-enrolled into the study.

For patients assigned to the TMS treatment group, the treatment protocol will consist of 20 sessions of TMS treatment. Each TMS session will deliver 5,000 pulses (120-140% MT, continuous temperature of 24C) over an 61 minute, 51 second time period. Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

For patients assigned to the iTBS treatment group, the treatment protocol will consist of 20 sessions of iTBS treatment. Each iTBS session will deliver 1,800 pulses (120-140% MT, continuous temperature of 24C) over an 9-minute-40-second period. Patients will have up to four iTBS sessions per day, five days a week, until their treatment is completed (approximately 1 week). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Major Depressive Disorder
* Score greater than 13 on the Beck Depression Inventory
* Failure to remit with 3 antidepressants
* At least 18 years of age
* Must be willing to comply with the study protocol
* English Proficiency

Exclusion Criteria:

* Hepatic impairment
* Significant cytopenia
* Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disease
* Neurodegenerative diseases
* Myeloproliferative disorders
* Sickle cell disease
* Subjects with scalp rash or open wounds on the scalp
* Women who are pregnant, may become pregnant, or are breastfeeding
* Subjects unable to give informed consent or in vulnerable categories, such as prisoners
* Subjects who would not be able to lay down without excessive movement
* Recent surgery or dental work within 3 months of the scheduled procedure
* Not English Proficient
* Advanced stages of any terminal illness or any active cancer that requires chemotherapy
* History of epilepsy or seizure, or history of such in first degree relative
* An increased risk of seizure for any reason
* Stents in the neck or brain
* Aneurysm clips or coils
* Metal devices/objects in or near the head
* Metallic implants near the ears and eyes
* Facial tattoos with metallic or magnetic-sensitive ink
* Comorbid psychiatric conditions

Primary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: 1 month
measure: Patient Depression Questionnaire (PDQ-9)
timeFrame: 1 month
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: 1 month
measure: Global Rating of Change (GRC)
timeFrame: 1 month
Secondary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: 2 months
measure: Patient Depression Questionnaire (PDQ-9)
timeFrame: 2 months
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: 2 months
measure: Global Rating of Change (GRC)
timeFrame: 2 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon E Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
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