Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

National Science Council, Taiwan0 sites80 target enrollmentJanuary 1, 2012

ConditionsDepression Treatment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression
Sponsor: National Science Council, Taiwan
Enrollment: 80
Primary Endpoint: Hamilton Rating Scale for Depression (HAMD)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2012

End Date

December 31, 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Science Council, Taiwan

Responsible Party

Principal Investigator

Kuan-Pin

China Medical University Hospital

National Science Council, Taiwan

Eligibility Criteria

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
•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)