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

Taipei Veterans General Hospital

Status: Completed

Conditions: Treatment Resistant Depression

Treatments: Device: Active standardized iTBS-DMPFC; Device: Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC; Device: Active high-dosage iTBS-DMPFC

Study type: Interventional

Funder types: Other

Identifiers

NCT04037592

2018-07-011C

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 3 patient groups

Active standardized iTBS-DMPFC

Experimental group

Description:

This active group will receive standardized dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)

Treatment:

Device: Active standardized iTBS-DMPFC

Active high-dosage iTBS-DMPFC

Experimental group

Description:

This active group will receive high dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)

Treatment:

Device: Active high-dosage iTBS-DMPFC

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

Sham Comparator group

Description:

Patients in the sham group will receive the same standardized or high-dosage iTBS performing by a sham coil

Treatment:

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