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

Primary Purpose

Depressive Disorder, Treatment-Resistant

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
iTBS-1800
iTBS-1200
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant focused on measuring Repetitive transcranial magnetic stimulation, Mood Disorders

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ChangGungMH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

iTBS-1800

iTBS-1200

Arm Description

The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

Outcomes

Primary Outcome Measures

Change in 17-item Hamilton Depression Rating Scale
17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)
Change in Montgomery-Asberg Depression Rating Scale
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
Change in Beck Anxiety Inventory
Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)

Secondary Outcome Measures

Response rate after 2-week treatment at the end of iTBS (HDRD-17 )
Improvement > 50 % of HDRD-17
Response rate after 2-week treatment at the end of iTBS (MADRS)
Improvement > 50 % of MADRS
Changes in Clinical Global Index Severity
Clinical Global Index
Changes in Heart Rate Variability (HRV) band
Heart rate variability measured by Wegene 8Z11
Changes in EEG band
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.
Change in BDNF
Changes in BDNF values
Change in TSH
Change in TSH values
Change in T3
Change in T3
Change in T4
Change in T4
Change in cortisol
Change in cortisol

Full Information

First Posted
April 13, 2022
Last Updated
May 20, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05390593
Brief Title
Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation
Acronym
iTBS
Official Title
Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant
Keywords
Repetitive transcranial magnetic stimulation, Mood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTBS-1800
Arm Type
Experimental
Arm Description
The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.
Arm Title
iTBS-1200
Arm Type
Experimental
Arm Description
The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
iTBS-1800
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
iTBS-1200
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 17-item Hamilton Depression Rating Scale
Description
17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)
Time Frame
Baseline, Week 1, Week 2, Week 4
Title
Change in Montgomery-Asberg Depression Rating Scale
Description
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
Time Frame
Baseline, Week 1, Week 2, Week 4
Title
Change in Beck Anxiety Inventory
Description
Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)
Time Frame
Baseline, Week 1, Week 2, Week 4
Secondary Outcome Measure Information:
Title
Response rate after 2-week treatment at the end of iTBS (HDRD-17 )
Description
Improvement > 50 % of HDRD-17
Time Frame
Baseline, Week 1, Week 2, Week 4
Title
Response rate after 2-week treatment at the end of iTBS (MADRS)
Description
Improvement > 50 % of MADRS
Time Frame
Baseline, Week 1, Week 2, Week 4
Title
Changes in Clinical Global Index Severity
Description
Clinical Global Index
Time Frame
Baseline, Week 1, Week 2, Week 4
Title
Changes in Heart Rate Variability (HRV) band
Description
Heart rate variability measured by Wegene 8Z11
Time Frame
Baseline, Week 1, Day 3, Week 2, Week 4
Title
Changes in EEG band
Description
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.
Time Frame
Baseline, Week 1, Day 3, Week 2, Week 4
Title
Change in BDNF
Description
Changes in BDNF values
Time Frame
Baseline, Week 2
Title
Change in TSH
Description
Change in TSH values
Time Frame
Baseline, Week 2
Title
Change in T3
Description
Change in T3
Time Frame
Baseline, Week 2
Title
Change in T4
Description
Change in T4
Time Frame
Baseline, Week 2
Title
Change in cortisol
Description
Change in cortisol
Time Frame
Baseline, Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis of major depressive disorder according to DSM-5 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. Before treatment, patient have to stop antidepressant for at least 1 weeks. Capable and willing to provide informed consent. Exclusion Criteria: 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. Intracranial implant and other ferromagnetic materials close to the head. History of Seizures. Cardiac pacemaker. Pregnancy.
Facility Information:
Facility Name
ChangGungMH
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation

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