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

Not Applicable

Completed

• Conditions: Treatment; Depression
• Interventions: Device: Sham; Device: TBS

• Registration Number: NCT04364880
• Lead Sponsor: National Science Council, Taiwan

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham controlled intervention	Sham	The sham-TBS coil produced a similar sound without a magnetic pulse.
Theta-burst stimulation (TBS)	TBS	Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.