Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder
ConditionMajor Depressive Diorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-23
SponsorZhifen Liu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
deep transcranial magnetic stimulation with H1coil
DeviceParticipants will receive dTMS treatment with H1 coil
deep transcranial magnetic stimulation with H7 coil
DeviceParticipants will receive dTMS treatment with H7 coil
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: H1 coilActive comparator 1 intervention
Group B: H7 coilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hamilton Depression Scale -24 (HAMD-24)
score change. Higher score means worse outcome.(Min = 0, Max = 76)
Time frame
From enrollment to the end of treatment at 12 weeks2
Response on Hamilton Depression Scale-24
Defined as a score reduction of 50% or more
Time frame
From enrollment to the end of treatment at 12 weeks3
Remission onHamilton Depression Scale-24
Defined as a score of 7 or less
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Hamilton Anxiety Rating Scale (HAM-A)
score change. Higher score means worse outcome.(Min = 0, Max = 56)
Time frame
From enrollment to the end of treatment at 12 weeks2
Snaith-Hamilton Pleasure Scale (SHAPS)
score change. Higher score means worse outcome.(Min= 0, Max = 56)
Time frame
From enrollment to the end of treatment at 12 weeks3
Beck Scale for Suicide Ideation-Chinese Version (BSI-CV)
score change. Higher score means worse outcome.(Min= 0, Max = 38)
Time frame
From enrollment to the end of treatment at 12 weeks4
Self-Injury Diary Card
Higher numeric value means worse outcome.
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhifen Liu
Lead sponsor
The First Affiliated Hospital of Shanxi Medical University
Sponsor institution
Source ClinicalTrials.gov