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

October 7, 2022 updated by: Kuan-Pin, National Science Council, Taiwan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Theta-burst stimulation (TBS)
Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
Device: 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.
Device: Sham
The sham-TBS coil produced a similar sound without a magnetic pulse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Weeks 0 to 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Weeks 0 to 24
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.
From Weeks 0 to 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Science Council, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

December 31, 2015

Study Completion (ACTUAL)

December 31, 2015

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHRI-EX101-10144NI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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