Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

Overview

This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2015

Detailed Description

This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.

Interventions

  • Device: TBS
    • Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
  • Device: Sham
    • The sham-TBS coil produced a similar sound without a magnetic pulse.

Arms, Groups and Cohorts

  • Experimental: Theta-burst stimulation (TBS)
    • Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
  • Sham Comparator: Sham controlled intervention
    • The sham-TBS coil produced a similar sound without a magnetic pulse.

Clinical Trial Outcome Measures

Primary Measures

  • Hamilton Rating Scale for Depression (HAMD)
    • Time Frame: From Weeks 0 to 24
    • The Hamilton Depression scale sum score (HAMD21) Not depressed: 0-7 Mild: 8-13 Moderate: 14-18 Severe: 19-22 Very severe: >23

Secondary Measures

  • Response rate
    • Time Frame: From Weeks 0 to 24
    • The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group.
  • Remission rate
    • Time Frame: From Weeks 0 to 24
    • The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission.

Participating in This Clinical Trial

Inclusion Criteria

  • The diagnostic criteria of DSM-IV for MDD – The range of the age from 18 to 70-year-old – Physically healthy on medical history, physical examination, and laboratory parameters within normal limits – Competent for a full explanation of the study and written informed consent is obtained. Exclusion Criteria:

  • Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded – Pregnant – History or family history of seizure disorder – Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain – Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Science Council, Taiwan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kuan-Pin, China Medical University Hospital – National Science Council, Taiwan
  • Overall Official(s)
    • Kuan-Pin Su, MD PhD, Principal Investigator, China Medical University Hospital

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