Status:
COMPLETED
Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
21-70 years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04037592
Start Date
July 24 2019
End Date
January 31 2021
Last Update
August 31 2022
Active Locations (1)
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1
Department of Psychiatry, Taipei Veterans General Hospital
Taipei, Taiwan, 112