Status:
ENROLLING_BY_INVITATION
Deep Versus Standard Prolonged Intermittent Theta Burst Stimulation for Depression
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Intermittent Theta Burst Stimulation
Repetitive Transcranial Magnetic Stimulation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study compares two types of non-invasive brain stimulation to treat major depression in patients who have not found relief from at least one antidepressant medication. The study will use a speci...
Detailed Description
Background: Major depressive disorder (MDD) is associated with dysfunction in large-scale brain networks, including the central executive network (CEN), default mode network (DMN), and the salience n...
Eligibility Criteria
Inclusion
- Ages between 18 and 70 years, inclusive.
- Diagnosis of Major Depressive Disorder (MDD) with a current major depressive episode, according to DSM-5 criteria, as confirmed by a psychiatrist.
- History of inadequate response to at least one trial of an antidepressant medication of adequate dose and duration.
- A score of 18 or greater on the 17-item Hamilton Depression Rating Scale (HAM-D17) at the screening visit.
Exclusion
- Lifetime diagnosis of any primary psychotic disorder (e.g., schizophrenia spectrum disorders) or bipolar and related disorders according to DSM-5.
- Significant current suicide risk, as indicated by a score of 4 on item 3 of the HAM-D17.
- Current substance use disorder (excluding tobacco) within the last 3 months, according to DSM-5.
- Presence of significant cognitive impairment, such as intellectual disability, delirium, or a diagnosed neurocognitive disorder.
- Any personal history of seizures, stroke, brain tumor, brain aneurysm, increased intracranial pressure, or other major neurological disorders.
- Presence of metal implants in the head (excluding dental fillings) or any implanted medical devices such as a cardiac pacemaker or defibrillator.
- Currently pregnant.
- Any other major medical condition that, in the investigator's judgment, could compromise participant safety or interfere with the study procedures.
Key Trial Info
Start Date :
November 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07198438
Start Date
November 24 2025
End Date
June 30 2027
Last Update
December 12 2025
Active Locations (1)
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1
Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch
Douliu, Yunlin County, Taiwan, 640