Clinical trial NCT04037592: Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients
Official title: Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients and Its Predictors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-07-30
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. standardized dosage intermittent theta-burst stimulation treatment, high dosage 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.
* Participants also failed to respond to one complete left-sided DLPFC 10Hz rTMS/piTBS treatment course.

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 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)
Secondary outcomes:
measure: Response rate after 3-week treatment at the end of iTBS sessions and three and six month after.
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)
measure: Remission rate after 3-week treatment
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)
measure: Changes in Clinical Global Index
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Changes in depression severity, rated by self-reported
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Changes in Young Mania Rating Scale
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 3
measure: Baseline brain connectivity and the further antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 3
measure: the change of brain connectivity after 3-week iTBS treatment
timeFrame: Baseline, Week 3
measure: Baseline Life event stress scale and the further antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 3
measure: Changes in EEG band before and after brain stimulation
timeFrame: Day 1(pre-RECT, post RECT, post 1st treatment, pre-30th treatment)
measure: Baseline single-pulse stimulation and the further antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 3
measure: Changes in single-pulse stimulation before and after brain stimulation
timeFrame: Baseline, Week 3
measure: Baseline paired-pulse stimulation and the further antidepressant efficacy of brain stimulation
timeFrame: Baseline, Week 3
measure: Changes in paired-pulse stimulation before and after brain stimulation
timeFrame: Baseline, Week 3
measure: Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale
timeFrame: Baseline, Week 1, Week 2, Week 3
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Department of Psychiatry, Taipei Veterans General Hospital
Study officials:
References: