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Tests treatment safety and results for Major Depressive Diorder
Official title Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder
ClinicalTrials.gov ID: NCT06728280
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 23
You may be able to join if
- 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...
- 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.
- people who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.
You likely can't join if
- A diagnosis of other psychiatric disorders in the DSM-5.
- Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing...
- History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant...
- 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)...
- There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments.
See the full eligibility criteria
- 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.
- people who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.
- A diagnosis of other psychiatric disorders in the DSM-5.
- 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.
- History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant head trauma.
- 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...
- There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments.
- Participation in any investigational drug trial within 6 months before the baseline visit.
- Other conditions that are not suitable for the study object in the researcher's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 23 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiyuan, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.