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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364880
• Other study ID #: NHRI-EX101-10144NI
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: October 2022
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Treatment

Intervention

Device:
• TBS
Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
• Sham
The sham-TBS coil produced a similar sound without a magnetic pulse.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Weeks 0 to 24
Secondary	Response rate	The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group.	From Weeks 0 to 24
Secondary	Remission rate	The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission.	From Weeks 0 to 24