Deep Versus Standard Prolonged Intermittent Theta Burst Stimulation for Depression
Enrolling by invitation · Not applicable
Conditions studied: Intermittent Theta Burst Stimulation, Repetitive Transcranial Magnetic Stimulation, Depression
In brief
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 specific type of brain stimulation called prolonged intermittent Theta Burst Stimulation (piTBS). The standard way to use piTBS for depression is to target an area on the side of the head called the dorsolateral prefrontal cortex (DLPFC). This study will compare this standard piTBS method with a newer approach, deep piTBS, which targets a different, deeper area in the middle of the brain called the anterior cingulate cortex (ACC). Participants will be randomly assigned to one of two groups. One group will receive the deep piTBS treatment, and the other will receive the standard piTBS treatment. Both treatments are given once a day, five days a week, for four weeks. The study aims to find out if the deep piTBS approach is more effective at reducing symptoms of depression than the standard approach. Researchers will also look at effects on anxiety and other related symptoms.
Key facts
- Study ID
- NCT07198438
- Run by
- National Taiwan University Hospital
- People needed
- 90
- Starts
- 2025-11-24
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch — Douliu, Yunlin County, Taiwan
Full record on ClinicalTrials.gov
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