NCT06372834Completed
Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients
Efficacy of Adjuvant Accelerated Prolonged Intermittent Theta Burst Stimulation for Reducing Suicidal Ideation in Therapy-resistant Depressed Patients: A Randomized, Sham-controlled Trial
Source: ClinicalTrials.gov · Last updated 13 May 2025
Brief summary (registry, in English)
In this double-blind, randomized, sham-controlled trial, the investigators aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. The investigators hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 15 Apr 2024
- Start date
- 29 Mar 2023
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Diseases
- Depression
- NCT number
- NCT06372834
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 29 Mar 2023 to the primary completion date, 20 Dec 2024
- 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.
Prior treatment
- Having previous intracranial surgery and ferromagnetic metallic implants in the head.
- History of treatment with electroconvulsive therapy (ECT) or no response to rTMS over the left DLPFC.
- In addition to those listed above, those who were deemed unsuitable for participating in this clinical trial by the medical judgment of the investigator due to other reasons (e.g., lack of competence to consent to research or any other contraindications to receiving rTMS).
Other illness
- Having MDD with psychotic features, bipolar disorder, schizophrenia, organic brain syndrome or active substance (except for tobacco and coffeine) use disorder.
- History of brain abnormalities (e.g., brain neoplasms, arteriovenous malformations, meningitis, encephalitis, epilepsy, neurodegenerative disorders).
Other
- Pregnancy at enrollment.
- Those who had attempted a suicide within six months from the screening date.
- Skin lesions on scalp at the area of coil application.
Who the study is looking for
- Subjects aged 20-65 years, met criteria for DSM-V major depressive disorder.
- A depression severity score of 18 or more on the 17-item Hamilton Rating Scale for Depression (HRSD-17) as well as a score of 1 or more on the item of the HDRS-17 (item 3).
- Meeting criteria for TRD defined as no clinical response to at least one adequate trial of one major class of antidepressants.
- Having been receiving stable antidepressant medications regimen for more than 4 weeks before enrollment and having their original medication regimen unchanged throughout the trial.
Age in the registry: 20 years to 65 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 |
|---|---|---|---|
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.