Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Disorder, Treatment-Resistant
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in 17-item Hamilton Depression Rating Scale
- Last Updated
- 3 years ago
Overview
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.
Investigators
Chih-Wei Hsu
Psychiatry Department
Chang Gung Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •The diagnosis of major depressive disorder according to DSM-5
- •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
- •Before treatment, patient have to stop antidepressant for at least 1 weeks.
- •Capable and willing to provide informed consent.
Exclusion Criteria
- •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.
- •Intracranial implant and other ferromagnetic materials close to the head.
- •History of Seizures.
- •Cardiac pacemaker.
Outcomes
Primary Outcomes
Change in 17-item Hamilton Depression Rating Scale
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 1, Week 2, Week 4
Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)
Secondary Outcomes
- Response rate after 2-week treatment at the end of iTBS (MADRS)(Baseline, Week 1, Week 2, Week 4)
- Changes in Clinical Global Index Severity(Baseline, Week 1, Week 2, Week 4)
- Changes in EEG band(Baseline, Week 1, Day 3, Week 2, Week 4)
- Change in TSH(Baseline, Week 2)
- Change in T3(Baseline, Week 2)
- Change in cortisol(Baseline, Week 2)
- Change in BDNF(Baseline, Week 2)
- Change in T4(Baseline, Week 2)
- Response rate after 2-week treatment at the end of iTBS (HDRD-17 )(Baseline, Week 1, Week 2, Week 4)
- Changes in Heart Rate Variability (HRV) band(Baseline, Week 1, Day 3, Week 2, Week 4)