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Completed

NCT Number: NCT04364880

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Treatment

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TBS

Device

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

SHAM

Device

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

Primary outcomes

  1. Hamilton Rating Scale for Depression (HAMD)

    Time frame: 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 outcomes

  1. Response rate

    Time frame: From Weeks 0 to 24

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

  2. Remission rate

    Time frame: From Weeks 0 to 24

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

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2020
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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