Status:
UNKNOWN
Transcranial Magnetic Stimulation vs Theta Burst Stimulation in Major Depressive Disorder
Lead Sponsor:
Neurological Associates of West Los Angeles
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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 assig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04497350
Start Date
January 6 2020
End Date
December 1 2024
Last Update
September 28 2022
Active Locations (1)
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1
Neurological Associates of West Los Angeles
Santa Monica, California, United States, 90403