NCT07198438Enrolling by invitation
Deep Versus Standard Prolonged Intermittent Theta Burst Stimulation for Depression
A Block-Randomized Study Comparing Deep and Standard Prolonged Intermittent Theta Burst Stimulation on Emotional Symptoms and Physiological Indicators in Patients With Major Depression
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 21 Sept 2025
- Start date
- 24 Nov 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Depression
- NCT number
- NCT07198438
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 24 Nov 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Lifetime diagnosis of any primary psychotic disorder (e.g., schizophrenia spectrum disorders) or bipolar and related disorders according to DSM-5.
- 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.
- Any other major medical condition that, in the investigator's judgment, could compromise participant safety or interfere with the study procedures.
Other
- Significant current suicide risk, as indicated by a score of 4 on item 3 of the HAM-D17.
- Currently pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch Coordinator of this site? Confirm its status | Douliu | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.