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

NCT04076124 | Unknown DMC

• 1 other identifier: V107C-123
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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 4(day 20)

Secondary Outcomes (10)

• Response rate after 4-week treatment at the end of TMS sessions and three month after.

  Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)

• Remission rate after 4-week treatment

  Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)

• Changes in Clinical Global Index

  Baseline, Week 1, Week 2, Week 3, Week 4(day 20)

• Changes in depression severity, rated by self-reported

  Baseline, Week 1, Week 2, Week 3, Week 4(day 20)

• Changes in Young Mania Rating Scale

  Baseline, Week 1, Week 2, Week 3, Week 4(day 20)

Study Arms (3)

Active rTMS-DLPFC

EXPERIMENTAL

This active group will receive high-frequency repetitive TMS stimulation.

Device: Active rTMS-DLPFC

Active iTBS-DLPFC

EXPERIMENTAL

This active group will receive intermittent theta-burst TMS stimulation.

Device: Active iTBS-DLPFC

Sham TBS-DLPFC or Sham rTMS-DLPFC

SHAM COMPARATOR

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

Interventions

Active rTMS-DLPFC DEVICE

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.

Active rTMS-DLPFC

Active iTBS-DLPFC DEVICE

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.

Active iTBS-DLPFC

Sham TBS-DLPFC or Sham rTMS-DLPFC DEVICE

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.

Sham TBS-DLPFC or Sham rTMS-DLPFC

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

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)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Psychiatry, Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Cheng-Ta Li, Professor

CONTACT

886 -2- 28757027; ctli2@vghtpe.gov.tw

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: September 3, 2019
• Study Start: July 24, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)