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Treatment Resistant DepressionNCT04037592

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

A study testing Active standardized iTBS-DMPFC and Active high-dosage iTBS-DMPFC in people with Treatment Resistant Depression, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Treatment Resistant Depression
What is being tested?
Active standardized iTBS-DMPFC and Active high-dosage iTBS-DMPFC
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteTaiwan
Study dates
24 Jul 2019to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Psychiatry, Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

About this study

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

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.

Being tested
Active standardized iTBS-DMPFC, Active high-dosage iTBS-DMPFC, Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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.

  • 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

Study groups in NCT04037592
Study groupRoleWhat they receive
Active standardized iTBS-DMPFCExperimentalThis active group will receive standardized dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)
Receives: Device: Active standardized iTBS-DMPFC
Active high-dosage iTBS-DMPFCExperimentalThis active group will receive high dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)
Receives: Device: Active high-dosage iTBS-DMPFC
Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFCSham comparatorPatients in the sham group will receive the same standardized or high-dosage iTBS performing by a sham coil
Receives: Device: Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (15)

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

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

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

  2. Remission rate after 3-week treatment

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

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

  3. Changes in Clinical Global Index

    Clinical Global Index

    Measured: Baseline, Week 1, Week 2, Week 3

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

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

    Measured: Baseline, Week 1, Week 2, Week 3

  5. Changes in Young Mania Rating Scale

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

    Measured: Baseline, Week 1, Week 2, Week 3

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

    Maudsley staging method

    Measured: Baseline, Week 3

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

    baseline functional MRI

    Measured: Baseline, Week 3

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

    the change in brain connectivity

    Measured: Baseline, Week 3

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

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

    Measured: Baseline, Week 3

  10. Changes in EEG band before and after brain stimulation

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

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

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

    baseline single-pulse stimulation

    Measured: Baseline, Week 3

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

    the change in single-pulse stimulation

    Measured: Baseline, Week 3

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

    baseline paired-pulse stimulation

    Measured: Baseline, Week 3

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

    the change in paired-pulse stimulation

    Measured: Baseline, Week 3

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

    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.

    Measured: Baseline, Week 1, Week 2, Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start24 Jul 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04037592
Sponsor's protocol ID
2018-07-011C
Status last verified
Aug 2022
First submitted
26 Jul 2019
Last updated
31 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36484844

Questions about this trial

What is this clinical trial studying?

A study testing Active standardized iTBS-DMPFC and Active high-dosage iTBS-DMPFC in people with Treatment Resistant Depression, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04037592, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.

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