Clinical trial NCT04076124: Brain-derived Neurotrophic Factor and the Antidepressant Efficacy of Brain Stimulation
Official title: Different Forms of Prefrontal Transcranial Stimulation and Brain-derived Neurotrophic Factor in the Prediction of Antidepressant Efficacy of Brain Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Resistant Depression
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Percentage change in 17-item Hamilton Depression Rating Scale
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Secondary outcomes:
measure: Response rate after 4-week treatment at the end of TMS sessions and three month after.
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
measure: Remission rate after 4-week treatment
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
measure: Changes in Clinical Global Index
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
measure: Changes in depression severity, rated by self-reported
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
measure: Changes in Young Mania Rating Scale
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
measure: The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 4(day 20)
measure: The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 4(day 20)
measure: The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 4(day 20)
measure: The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 4(day 20)
measure: Changes in EEG band before and after brain stimulation
timeFrame: Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Department of Psychiatry, Taipei Veterans General Hospital
Study officials:
References: