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

National Science and Technology Council, Taiwan80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Depression Treatment

Interventions

TBSDEVICE

Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)

ShamDEVICE

The sham-TBS coil produced a similar sound without a magnetic pulse.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Hamilton Rating Scale for Depression (HAMD)

The Hamilton Depression scale sum score (HAMD21) * Not depressed: 0-7 * Mild: 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: \>23

Time frame: From Weeks 0 to 24

Secondary Outcomes

Response rate

The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group.

Time frame: From Weeks 0 to 24

Remission rate

The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission.

Time frame: From Weeks 0 to 24

Data from ClinicalTrials.gov

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