Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation

Not Applicable

• Conditions: Depressive Disorder, Treatment-Resistant
• Interventions: Device: iTBS-1800; Device: iTBS-1200

• Registration Number: NCT05390593
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-04-30
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iTBS-1800	iTBS-1800	The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.
iTBS-1200	iTBS-1200	The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
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)
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)
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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ChangGungMH; 🇨🇳 Kaohsiung, Taiwan