NCT06728280Recruiting
Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder
Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil. The main questions it aims to answer are: Type of study: Clinical trial. Participant population: Adolescents with major depressive disorder (MDD). Objective: To explore whether the H7 coil is no less effective than the H1 coil for adolescents with MDD, further providing clinicians with additional treatment options for patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 31 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Zhifen Liu
- Diseases
- Depression
- NCT number
- NCT06728280
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 31 Dec 2024 to the primary completion date, 31 Dec 2025
- 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
- Have obvious suicide risk, or have actual suicide behavior within 6 months before the screening.
- History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial Direct Current Stimulation (tDCS), or transcranial Alternating Current Stimulation (tACS) treatments for any disorders.
- Participation in any investigational drug trial within 6 months before the baseline visit.
Other illness
- A diagnosis of other psychiatric disorders in the DSM-5.
- History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant head trauma.
- Other conditions that are not suitable for the study object in the researcher's judgment.
Lab values
- Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study.
Other
- There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments.
Who the study is looking for
- Patients of all genders, aged between 11 and 23 years old, and right-handedness.
- In accordance with the diagnostic criteria for the major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I).
- Beck Depression Inventory, Second Edition (BDI-II): total BDI-II score\> 13 at screening.
- Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.
Age in the registry: 11 years to 23 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 |
|---|---|---|---|
| Deep Transcranial Magnetic Stimulation Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.