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

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05390593
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Treatment-Resistant	Device: iTBS-1800; Device: iTBS-1200	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in 17-item Hamilton Depression Rating Scale [Baseline, Week 1, Week 2, Week 4]

   17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)

2. Change in Montgomery-Asberg Depression Rating Scale [Baseline, Week 1, Week 2, Week 4]

   Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)

3. Change in Beck Anxiety Inventory [Baseline, Week 1, Week 2, Week 4]

   Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)

Secondary Outcome Measures

1. Response rate after 2-week treatment at the end of iTBS (HDRD-17 ) [Baseline, Week 1, Week 2, Week 4]

   Improvement > 50 % of HDRD-17

2. Response rate after 2-week treatment at the end of iTBS (MADRS) [Baseline, Week 1, Week 2, Week 4]

   Improvement > 50 % of MADRS

3. Changes in Clinical Global Index Severity [Baseline, Week 1, Week 2, Week 4]

   Clinical Global Index

4. Changes in Heart Rate Variability (HRV) band [Baseline, Week 1, Day 3, Week 2, Week 4]

   Heart rate variability measured by Wegene 8Z11

5. Changes in EEG band [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.

6. Change in BDNF [Baseline, Week 2]

   Changes in BDNF values

7. Change in TSH [Baseline, Week 2]

   Change in TSH values

8. Change in T3 [Baseline, Week 2]

   Change in T3

9. Change in T4 [Baseline, Week 2]

   Change in T4

10. Change in cortisol [Baseline, Week 2]

    Change in cortisol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Intracranial implant and other ferromagnetic materials close to the head.

2. History of Seizures.

3. Cardiac pacemaker.

4. Pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ChangGungMH	Kaohsiung		Taiwan	833

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chih-Wei Hsu, Psychiatry Department, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05390593
• Other Study ID Numbers: CMRPG8L0871
• First Posted: May 25, 2022
• Last Update Posted: May 25, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Chih-Wei Hsu, Psychiatry Department, Chang Gung Memorial Hospital: Repetitive transcranial magnetic stimulation; Mood Disorders
• Additional relevant MeSH terms: Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Study Results

No Results Posted as of May 25, 2022