the Safety and Effectiveness of Precise rTMS Based on Neuroimaging in the Treatment of Adolescent Depression With Anhedoniadepression With Anhedonia

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

This study evaluates a schedule of precise repetitive transcranial magnetic stimulation for depressive adolescent with anhedonia. In this randomized controlled trial, half of the participants will receive repetitive transcranial magnetic stimulation, and the other will receive sham stimulation.

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

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression among adult. The approved method for treatment is 10Hz stimulation over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been successful for many people with treatment-resistant depression. However, a large percentage of adolescents suffering from major depressive disorder (MDD) do not adequately benefit from currently available treatments. One of the limitations is concerns about the safety and efficacy of antidepressant. Recently, researchers have aggressively pursued better treatment strategy such as rTMS to improve adolescent depression with some preliminary success. This study intends to further explore the safety and efficacy of rTMS in the treatment for adolescent major depressive disorder with anhedonia. This study will also look at the change in neuroimaging biomarkers associated with this treatment.

Connect with a study center

  • Xijing Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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