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Completed

NCT Number: NCT04037592

Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients

This study evaluates an association between different dosage and the antidepressant efficacy of theta burst stimulation in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e. standardized dosage intermittent theta-burst stimulation treatment, high dosage intermittent theta-burst stimulation treatment or sham treatment.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female, 21 to 70 years of age.
  • Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
  • Participants failed to respond to at least one adequate antidepressant treatment in their current episode
  • Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
  • Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.
  • Participants also failed to respond to one complete left-sided DLPFC 10Hz rTMS/piTBS treatment course.

Exclusion criteria

  • a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
  • Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
  • Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
  • Women with breastfeeding or pregnancy
  • Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)

Treatment and study plan

Active standardized iTBS-DMPFC

Device

Participants in the standardized dosage(600 pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.

Active high-dosage iTBS-DMPFC

Device

Participants in the standardized dosage(1800pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.

Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC

Device

Half of the patients in the sham group received 3-week the same standardized iTBS parameter stimulation (standardized sham-iTBS), and the other half received the same high dosage iTBS parameter stimulation using a sham coil (high dosage sham-rTMS), which also improved the blinding process

Primary outcomes

  1. Percentage change in 17-item Hamilton Depression Rating Scale

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)

    the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)

Secondary outcomes

  1. Response rate after 3-week treatment at the end of iTBS sessions and three and six month after.

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)

    improvement > 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)

  2. Remission rate after 3-week treatment

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)

    17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)

  3. Changes in Clinical Global Index

    Time frame: Baseline, Week 1, Week 2, Week 3

    Clinical Global Index

  4. Changes in depression severity, rated by self-reported

    Time frame: Baseline, Week 1, Week 2, Week 3

    Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.

  5. Changes in Young Mania Rating Scale

    Time frame: Baseline, Week 1, Week 2, Week 3

    Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.

  6. Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation

    Time frame: Baseline, Week 3

    Maudsley staging method

  7. Baseline brain connectivity and the further antidepressant efficacy of brain stimulation

    Time frame: Baseline, Week 3

    baseline functional MRI

  8. the change of brain connectivity after 3-week iTBS treatment

    Time frame: Baseline, Week 3

    the change in brain connectivity

  9. Baseline Life event stress scale and the further antidepressant efficacy of brain stimulation

    Time frame: Baseline, Week 3

    Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress.

  10. Changes in EEG band before and after brain stimulation

    Time frame: Day 1(pre-RECT, post RECT, post 1st treatment, pre-30th treatment)

    Perform rostral anterior cingulate cortex(rACC)-engaging cognitive task(RECT) before 1-st treatment

  11. Baseline single-pulse stimulation and the further antidepressant efficacy of brain stimulation

    Time frame: Baseline, Week 3

    baseline single-pulse stimulation

  12. Changes in single-pulse stimulation before and after brain stimulation

    Time frame: Baseline, Week 3

    the change in single-pulse stimulation

  13. Baseline paired-pulse stimulation and the further antidepressant efficacy of brain stimulation

    Time frame: Baseline, Week 3

    baseline paired-pulse stimulation

  14. Changes in paired-pulse stimulation before and after brain stimulation

    Time frame: Baseline, Week 3

    the change in paired-pulse stimulation

  15. Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale

    Time frame: Baseline, Week 1, Week 2, Week 3

    the altered anxiosomatic cluster symptoms (range, 0 to 26, with higher scores indicating more severe anxiosomatic symptoms).The anxiosomatic cluster symptoms comprised nine items derived from HDRS-17: early insomnia, middle insomnia, slowness or retardation, psychic anxiety, autonomic anxiety, gastrointestinal symptoms, somatic symptoms, genital symptoms, and hypochondriasis.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients and Its Predictors

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Aug 31, 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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