Brain-derived Neurotrophic Factor and the Antidepressant Efficacy of Brain Stimulation

August 29, 2019 updated by: Taipei Veterans General Hospital, Taiwan

Different Forms of Prefrontal Transcranial Stimulation and Brain-derived Neurotrophic Factor in the Prediction of Antidepressant Efficacy of Brain Stimulation

This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 112
        • Recruiting
        • Department of Psychiatry, Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS-DLPFC
This active group will receive high-frequency repetitive TMS stimulation.
Device: Active rTMS-DLPFC
Participants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
Experimental: Active iTBS-DLPFC
This active group will receive intermittent theta-burst TMS stimulation.
Device: Active iTBS-DLPFC
Participants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
Sham Comparator: Sham TBS-DLPFC or Sham rTMS-DLPFC
Patients in the sham group will receive the same iTBS or rTMS parameter stimulation, performing by a sham coil.
Device: Sham TBS-DLPFC or Sham rTMS-DLPFC
Half of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in 17-item Hamilton Depression Rating Scale
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
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 4(day 20)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate after 4-week treatment at the end of TMS sessions and three month after.
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
improvement > 50 % 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 4, week 16 (day 80)
Remission rate after 4-week treatment
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)
Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
Changes in Clinical Global Index
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Clinical Global Index
Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Changes in depression severity, rated by self-reported
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.
Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Changes in Young Mania Rating Scale
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.
Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation
Time Frame: Baseline, Week 4(day 20)
Val/Val, Met/Met, Val/Met genotype and the efficacy after receiving 4-week treatment. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale
Baseline, Week 4(day 20)
The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation
Time Frame: Baseline, Week 4(day 20)
baseline PET/MRI.The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Baseline, Week 4(day 20)
The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation
Time Frame: Baseline, Week 4(day 20)
Maudsley staging method. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Baseline, Week 4(day 20)
The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation
Time Frame: Baseline, Week 4(day 20)
Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Baseline, Week 4(day 20)
Changes in EEG band before and after brain stimulation
Time Frame: Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment)
Perform rACC-engaging cognitive task(RECT) before 1-st treatment
Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V107C-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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