Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation

Depressive Disorder, Treatment-Resistant Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05390593
• Other study ID #: CMRPG8L0871
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	ChangGungMH	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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