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Trial record 12 of 173 for:    Recruiting, Not yet recruiting, Available Studies | psychiatric disorder OR bipolar OR depression | Brain Stimulation

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

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ClinicalTrials.gov Identifier: NCT04076124
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: Active rTMS-DLPFC Device: Active iTBS-DLPFC Device: Sham TBS-DLPFC or Sham rTMS-DLPFC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Different Forms of Prefrontal Transcranial Stimulation and Brain-derived Neurotrophic Factor in the Prediction of Antidepressant Efficacy of Brain Stimulation
Actual Study Start Date : July 24, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Changes in Clinical Global Index [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20) ]
    Clinical Global Index

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076124


Contacts
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Contact: Cheng-Ta Li, Professor 886 -2- 28757027 ext 298 ctli2@vghtpe.gov.tw

Locations
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Taiwan
Department of Psychiatry, Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 112
Contact: Cheng-Ta Li, Professor    +886-2-28757027 ext 298    ctli2@vghtpe.gov.tw; on5083@msn.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04076124     History of Changes
Other Study ID Numbers: V107C-123
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs