Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients

Taipei Veterans General Hospital, Taiwan34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Treatment Resistant Depression

Interventions

Active standardized iTBS-DMPFCDEVICE

Participants in the standardized dosage(600 pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.

Active high-dosage iTBS-DMPFCDEVICE

Participants in the standardized dosage(1800pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.

Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Department of Psychiatry, Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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)

Time frame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)

Secondary Outcomes

Response rate after 3-week treatment at the end of iTBS sessions and three and six month after.

improvement \> 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)

Time frame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)

Remission rate after 3-week treatment

17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)

Time frame: Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)

Changes in Clinical Global Index

Clinical Global Index

Time frame: Baseline, Week 1, Week 2, Week 3

Changes in depression severity, rated by self-reported

Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.

Time frame: Baseline, Week 1, Week 2, Week 3

Changes in Young Mania Rating Scale

Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.

Time frame: Baseline, Week 1, Week 2, Week 3

Data from ClinicalTrials.gov

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