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Efficacy and Brain Imaging Mechanism of Precise rTMS in Treating Adolescent Depression With Anhedonia

Sponsor
Xijing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05544071
Collaborator
(none)
90
Enrollment
2
Arms
27.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Adolescent patients with depression with loss of pleasure were recruited for magnetic resonance imaging, and compared with healthy adolescents to explore the difference between brain imaging. A randomized controlled study was used to observe the efficacy and safety of accurate rTMS based on functional connection in the treatment of adolescent depression

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
 N/A

Detailed Description

Adolescent depressive patients with loss of pleasure and healthy adolescents were recruited (nasty 30). Magnetic resonance imaging was performed on the subjects to find out the difference between the two brain images. With DLPFC-NAcc functional connection as the stimulation target, adolescent patients with depression (nude 90) were randomly divided into transcranial magnetic stimulation group (drug combined with TMS treatment group) and control group (drug combined with TMS pseudo stimulation group) for 15 days respectively. At the baseline, at the end of 7 days, at the end of 15 days, at the end of 15 days, 4 weeks and 8 weeks, the changes of subjects' pleasure were evaluated by Snaith-Hamilton Pleasure Scale (SHAPS). Hamilton Depression Scale （HAMD- 17） was used to evaluate the changes of depressive symptoms. Structural and functional MRI scans were performed on the experimental cases at baseline and after treatment, and the brain structure and function before and after treatment were evaluated.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Brain Imaging Mechanism of Precise rTMS in Treating Adolescent Depression With Anhedonia
Anticipated Study Start Date :
Sep 13, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcranial magnetic stimulation group

Transcranial magnetic stimulation and drug therapy

Device: Transcranial Magnetic Stimulation
The transcranial magnetic stimulation group was treated with rTMS true stimulation and sertraline, and the pseudo stimulation group was treated with reversal magnetic head pseudo stimulation and sertraline treatment.
Other Names:
  • Sertraline

    		•
    Sham Comparator: Pseudo-stimulation group

    Pseudo-stimulation and drug therapy

    Device: Transcranial Magnetic Stimulation
    The transcranial magnetic stimulation group was treated with rTMS true stimulation and sertraline, and the pseudo stimulation group was treated with reversal magnetic head pseudo stimulation and sertraline treatment.
    Other Names:
  • Sertraline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Score changes of SHAPS scale in patients [After 4 weeks of treatment]

      Snaith-Hamilton Pleasure Scale ( SHAPS )

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. 14-18 years old, right-handed.

    2. accorded with the diagnostic criteria of major depressive disorder in the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

    3. the total score of HAMD-17 > 17.

    4. the total score of SHAPS > 20.

    5. after fully understanding the treatment of transcranial magnetic stimulation, they were willing to actively cooperate with the treatment and sign informed consent.

    Exclusion Criteria:

    1. has a history of severe somatic diseases or diseases that may affect the central nervous system (such as tumors, syphilis, etc.).

    2. nervous system diseases or risk of seizures, such as previous craniocerebral diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of brain structural abnormalities, or family history of epilepsy.

    3. patients with depression caused by bipolar disorder and other mental disorders (such as psychoactive substances and independent substances).

    4. contraindications for MRI scanning or transcranial magnetic stimulation, such as metal or electronic devices (metal foreign bodies such as intracranial metal foreign bodies, cochlear implants, pacemakers and stents, etc.).

    5. psychotic symptoms requiring combined use of antipsychotic drugs.

    6. mental retardation.

    7. receiving ECT treatment within 2 months before entering the group.

    8. other conditions judged by the researchers to be unsuitable for the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT05544071
    Other Study ID Numbers:
    • KY20222165-F-1
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anhedonia
    Depression
    Depressive Disorder
    Sertraline

    Study Results

    No Results Posted as of Sep 16, 2022