Depressive Disorder, Treatment-Resistant
Conditions
Keywords
Repetitive transcranial magnetic stimulation, Mood Disorders
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.
Interventions
DEVICEiTBS-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.
DEVICEiTBS-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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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. 2. Intracranial implant and other ferromagnetic materials close to the head. 3. History of Seizures. 4. Cardiac pacemaker. 5. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Heart Rate Variability (HRV) band | Baseline, Week 1, Day 3, Week 2, Week 4 | Heart rate variability measured by Wegene 8Z11 |
| 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 BDNF | Baseline, Week 2 | Changes in BDNF values |
| 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 |
| Change in T3 | Baseline, Week 2 | Change in T3 |
| Change in T4 | Baseline, Week 2 | Change in T4 |
| Change in cortisol | Baseline, Week 2 | Change in cortisol |
| Change in TSH | Baseline, Week 2 | Change in TSH values |
| 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 |
Countries
Taiwan
Outcome results
None listed