Status:
ENROLLING_BY_INVITATION
Resonant Frequency rTMS: A Novel Approach to Target Circuit Modulation in Major Depressive Disorder
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
MDD
Depression
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of the study is to develop a more personalized brain stimulation using repetitive transcranial magnetic stimulation or rTMS approach to treat major depressive disorder (MDD). The investiga...
Detailed Description
Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective treatment for Major Depressive Disorder (MDD), but response rates are highly variable across individuals. Clinical improvement with ...
Eligibility Criteria
Inclusion
- All subjects must be between 21-75 years of age.
- Must have confirmed diagnosis of severe \*Major Depressive Disorder (single or recurrent episode) as confirmed by the Mini-International Neuropsychiatric Interview (MINI) or/and a score of 17 or above on the Hamilton Depression Rating Scale (HAMD).
- Failure to respond to a minimum of 2 trials of antidepressant medication.
- Failure to respond from at least two different agent classes.
- Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
- Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
- Subjects are willing and able to adhere to the treatment schedule and required study visits.
- TMS treatment is clinically-approved only for those suffering from Major Depressive Disorder as their primary diagnosis.
Exclusion
- Are mentally or legally incapacitated, unable to give informed consent
- Have an infection or poor skin condition over the scalp where the device will be positioned.
- Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure.
- Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
- Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
- Presence of an implanted magnetic-sensitive medical device present in the body scan, located less than or equal to 30 centimeters from the transcranial magnetic stimulation magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI.)
- Current diagnosis of substance use disorder.
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06572683
Start Date
February 12 2024
End Date
October 31 2028
Last Update
September 22 2025
Active Locations (1)
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1
University of California
Los Angeles, California, United States, 90024