NCT05422417

Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression

Status unknown NA Last updated 17 August 2022

What this trial tests

NA trial testing Prolonged intermittent theta burst stimulation (piTBS) in Treatment-resistant Depression in 75 participants. Status unknown.

Timeline

7 June 2022

Primary endpoint
30 September 2025

31 December 2025

Quick facts

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	75
Start date	7 June 2022
Primary completion	30 September 2025
Estimated completion	31 December 2025
Sites	1 location across Taiwan

Drugs / interventions tested

• Prolonged intermittent theta burst stimulation (piTBS)
• 20Hz rTMS
• sham control — full drug profile →

Conditions studied

• Treatment-resistant Depression — all drugs for Treatment-resistant Depression →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Taipei Veterans General Hospital, Taiwan

Who can join

Adults 21 to 70, any sex, with Treatment-resistant Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Major depressive disorder (MDD) is a common and troublesome disorder, with high risk of physical and psychiatric comorbidity. At least one-third of patients could not achieve a response after several antidepressant trials, so-called treatment-refractory depression (TRD). The high-frequency repetitive transcranial magnetic stimulation (rTMS) or intermittent theta-burst stimulation (iTBS) at left-sided dorsolateral prefrontal cortex (DLPFC) have a response rate of 40-60%. Obviously, not all TRD patients achieve the remitted state after treatment with antidepressants or DLPFC-rTMS, which may result from the heterogeneity of MDD. More and more evidence, such as brain lesion studies, deep brain stimulation, open-labeled rTMS case series, and neuroimaging studies, suggests that dorsomedial prefrontal cortex (DMPFC) might play a more central role in the pathophysiology of major depression. The DMPFC demonstrated as a "dorsal nexus" phenomenon in depression, which means a unique brain region where cortical networks for affect regulation, default mode control and cognitive control coverage in depressed subjects but not in healthy persons. In addition, another meta-analysis of resting-state functional MRI (fMRI) demonstrated the abnormal functional connectivity from DMPFC. These abnormalities of networks were highly associated with several depressive symptoms such as anhedonia, emotional regulation, somatic markers, rumination, self-reflection, poor attention and poor decision-making. However, only a handful of studies investigated the brain stimulation targeting DMPFC and the further changes in brain functional connectivity. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.