NCT04037592

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

July 26, 2019

Last Update Submit

August 28, 2022

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

  • Percentage change in 17-item Hamilton Depression Rating Scale

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

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

Secondary Outcomes (15)

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

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

  • Remission rate after 3-week treatment

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

  • Changes in Clinical Global Index

    Baseline, Week 1, Week 2, Week 3

  • Changes in depression severity, rated by self-reported

    Baseline, Week 1, Week 2, Week 3

  • Changes in Young Mania Rating Scale

    Baseline, Week 1, Week 2, Week 3

  • +10 more secondary outcomes

Study Arms (3)

Active standardized iTBS-DMPFC

EXPERIMENTAL

This active group will receive standardized dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)

Device: Active standardized iTBS-DMPFC

Active high-dosage iTBS-DMPFC

EXPERIMENTAL

This active group will receive high dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)

Device: Active high-dosage iTBS-DMPFC

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

SHAM COMPARATOR

Patients in the sham group will receive the same standardized or high-dosage iTBS performing by a sham coil

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

Interventions

Active standardized iTBS-DMPFCDEVICE

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 standardized iTBS-DMPFC
Active high-dosage iTBS-DMPFCDEVICE

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.

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

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

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

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

  • Cheng CM, Li CT, Jeng JS, Chang WH, Lin WC, Chen MH, Bai YM, Tsai SJ, Su TP. Antidepressant effects of prolonged intermittent theta-burst stimulation monotherapy at the bilateral dorsomedial prefrontal cortex for medication and standard transcranial magnetic stimulation-resistant major depression: a three arm, randomized, double blind, sham-controlled pilot study. Eur Arch Psychiatry Clin Neurosci. 2023 Oct;273(7):1433-1442. doi: 10.1007/s00406-022-01523-4. Epub 2022 Dec 9.

    PMID: 36484844DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

July 24, 2019

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)