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

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: Active, not recruiting
• Conditions: Depressive Disorder, Treatment-Resistant
• Intervention / Treatment: Device: iTBS-1800; Device: iTBS-1200

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • ChangGungMH

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	Baseline, Week 1, Week 2, Week 4
Change in Montgomery-Asberg Depression Rating Scale	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	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

Outcome Measure	Measure Description	Time Frame
Response rate after 2-week treatment at the end of iTBS (HDRD-17 )	Improvement > 50 % of HDRD-17	Baseline, Week 1, Week 2, Week 4
Response rate after 2-week treatment at the end of iTBS (MADRS)	Improvement > 50 % of MADRS	Baseline, Week 1, Week 2, Week 4
Changes in Clinical Global Index Severity	Clinical Global Index	Baseline, Week 1, Week 2, Week 4
Changes in Heart Rate Variability (HRV) band	Heart rate variability measured by Wegene 8Z11	Baseline, Week 1, Day 3, Week 2, Week 4
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.	Baseline, Week 1, Day 3, Week 2, Week 4
Change in BDNF	Changes in BDNF values	Baseline, Week 2
Change in TSH	Change in TSH values	Baseline, Week 2
Change in T3	Change in T3	Baseline, Week 2
Change in T4	Change in T4	Baseline, Week 2
Change in cortisol	Change in cortisol	Baseline, Week 2

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Mood Disorders; Repetitive transcranial magnetic stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
• Other Study ID 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