Last updated: November 1, 2023
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Depression
Depression (Major/severe)
Depression (Adult And Geriatric)
Treatment
Transcranial Magnetic Stimulation (TMS)
Clinical Study ID
NCT05544071
KY20222165-F-1
Ages 13-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, 13 to 18 years of age.
- According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a MajorDepressive Episode (MDE).
- Meet the threshold on the total HAMD17 score of >/=17 at both screening and baselinevisits (Day -7 and Day 0).
- Meet the threshold on the total SHAPS score of >/=20 at both screening and baselinevisits (Day -7 and Day 0).
- Not take any antidepressants for two or more weeks before screening.
- In good general health, as ascertained by medical history.
- After fully understanding the treatment of transcranial magnetic stimulation, willingto cooperate with the treatment actively and able to provide informed consent.
Exclusion
Exclusion Criteria:
- Current diagnosis of a Substance Use Disorder, with the exception of nicotine andcaffeine dependence.
- Current diagnosis of mental disorders other than Dysthymic Disorder, GeneralizedAnxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or SpecificPhobia (unless one of these is clinically unstable, and/or the focus of theparticipant's treatment for the past six months or more).
- History of schizophrenia or schizoaffective disorders, or any history of psychoticsymptoms in the current or previous depressive episodes.
- Any other Mental Disorders, Personality Disorders, Intellectual Disability, which atscreening is clinically predominant to their MDD.
- Has a clinically significant abnormality on the screening examination that mightaffect safety, study participation, or confound interpretation of study results.
- Any current or past history of any physical condition which in the investigator'sopinion might put the subject at risk or interfere with study results interpretation.
- Participation in any clinical trial with an investigational drug or device within thepast month or concurrent to study participation.
- History of electronic instrument or metal in the head or skull.
- History of epilepsy.
- History of cardiovascular disease or cardiac event.
- History of OCD.
- History of autism spectrum disorder.
- History of rTMS exposure.
- Other situations judged by the researchers to be unsuitable for the study.
Study Design
Total Participants: 88
Treatment Group(s): 1
Primary Treatment: Transcranial Magnetic Stimulation (TMS)
Phase:
Study Start date:
February 12, 2023
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Xijing Hospital
Xi'an, Shaanxi 710032
ChinaActive - Recruiting
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