Depression, Treatment
Conditions
Keywords
depression, transcranial magnetic stimulation, theta-burst stimulation
Brief summary
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
Detailed description
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.
Interventions
DEVICETBS
Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
DEVICESham
The sham-TBS coil produced a similar sound without a magnetic pulse.
Sponsors
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The diagnostic criteria of DSM-IV for MDD * The range of the age from 18 to 70-year-old * Physically healthy on medical history, physical examination, and laboratory parameters within normal limits * Competent for a full explanation of the study and written informed consent is obtained.
Exclusion criteria
* Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded * Pregnant * History or family history of seizure disorder * Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain * Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HAMD) | From Weeks 0 to 24 | The Hamilton Depression scale sum score (HAMD21) * Not depressed: 0-7 * Mild: 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: \>23 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | From Weeks 0 to 24 | The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group. |
| Remission rate | From Weeks 0 to 24 | The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission. |
Outcome results
None listed