Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation (iTBS)

May 20, 2022 updated by: Chih-Wei Hsu, Chang Gung Memorial Hospital

Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis

The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • ChangGungMH

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The diagnosis of major depressive disorder according to DSM-5
  2. Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
  3. Before treatment, patient have to stop antidepressant for at least 1 weeks.
  4. Capable and willing to provide informed consent.

Exclusion Criteria:

  1. Have a concomitant major, unstable medical or neurologic illness :

    • Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
    • Severe brian disease: Brain tumor, encephalitis, brian injury.
  2. Intracranial implant and other ferromagnetic materials close to the head.
  3. History of Seizures.
  4. Cardiac pacemaker.
  5. Pregnancy.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: iTBS-1800
The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.
Device: iTBS-1800
Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG & More stimulator.
Experimental: iTBS-1200
The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.
Device: iTBS-1200
Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG & More stimulator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 17-item Hamilton Depression Rating Scale
Time Frame: Baseline, Week 1, Week 2, Week 4
17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)
Baseline, Week 1, Week 2, Week 4
Change in Montgomery-Asberg Depression Rating Scale
Time Frame: Baseline, Week 1, Week 2, Week 4
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
Baseline, Week 1, Week 2, Week 4
Change in Beck Anxiety Inventory
Time Frame: Baseline, Week 1, Week 2, Week 4
Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)
Baseline, Week 1, Week 2, Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Response rate after 2-week treatment at the end of iTBS (HDRD-17 )
Time Frame: Baseline, Week 1, Week 2, Week 4
Improvement > 50 % of HDRD-17
Baseline, Week 1, Week 2, Week 4
Response rate after 2-week treatment at the end of iTBS (MADRS)
Time Frame: Baseline, Week 1, Week 2, Week 4
Improvement > 50 % of MADRS
Baseline, Week 1, Week 2, Week 4
Changes in Clinical Global Index Severity
Time Frame: Baseline, Week 1, Week 2, Week 4
Clinical Global Index
Baseline, Week 1, Week 2, Week 4
Changes in Heart Rate Variability (HRV) band
Time Frame: Baseline, Week 1, Day 3, Week 2, Week 4
Heart rate variability measured by Wegene 8Z11
Baseline, Week 1, Day 3, Week 2, Week 4
Changes in EEG band
Time Frame: Baseline, Week 1, Day 3, Week 2, Week 4
Changes in EEG band before and after brain stimulation. Subject EEG activity including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands.
Baseline, Week 1, Day 3, Week 2, Week 4
Change in BDNF
Time Frame: Baseline, Week 2
Changes in BDNF values
Baseline, Week 2
Change in TSH
Time Frame: Baseline, Week 2
Change in TSH values
Baseline, Week 2
Change in T3
Time Frame: Baseline, Week 2
Change in T3
Baseline, Week 2
Change in T4
Time Frame: Baseline, Week 2
Change in T4
Baseline, Week 2
Change in cortisol
Time Frame: Baseline, Week 2
Change in cortisol
Baseline, Week 2

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMRPG8L0871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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