Neuromodulation for treatment-resistant depression
New Form of Brain Stimulation Targeting Dorsomedial Prefrontal Cortex in Treating Refractory Depression and the Predictive Biomarkers of Antidepressant Efficacy
This study is testing two different brain stimulation techniques to see if they can help people with treatment-resistant depression who haven't found relief with regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05422417 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz repetitive transcranial magnetic stimulation (rTMS) targeting the dorsomedial prefrontal cortex (DMPFC) in patients with treatment-resistant depression (TRD). Participants who have not responded to at least one antidepressant will be randomized into three groups: one receiving piTBS, another receiving 20Hz-rTMS, and a sham control group. The study will assess clinical outcomes and brain activity changes through functional and structural MRI before and after treatment to understand the effects of DMPFC stimulation on depression. This approach aims to provide insights into the brain networks involved in depression and improve treatment strategies for TRD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with recurrent major depressive disorder who have not responded to at least one adequate antidepressant treatment.
Not a fit: Patients who have not been diagnosed with major depressive disorder or those who have not failed any antidepressant treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients suffering from treatment-resistant depression.
How similar studies have performed: Preliminary open-label studies have shown efficacy for DMPFC stimulation, but this trial aims to confirm these findings through a randomized sham-controlled approach, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with a recurrent major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. Diagnoses were established after taking a thorough medical history and conducting a semistructured interview by administering the Mini International Neuropsychiatric Interview (MINI); 2. Recruited participants had to have a Clinical Global Impression - Severity score of at least four and a total score of at least 18 on the 17-items Hamilton Depression Rating Scale (HDRS-17); 3. Patients were qualified if they failed to respond to at least one adequate antidepressant treatment in their current episode (for example, failed to achieve 50% improvement of depression to an equivalent daily dose of 10 to 20 mg of escitalopram for at least eight weeks); 4. Stabilized treatment: keeping current antidepressant drug treatment, including the dose at least for four weeks before this trial and during the trial period; keep the stabilized psychotherapy at least for three months and no anticipated adjustment of types of psychotherapy and the frequency. Exclusion Criteria: 1. Patients with Bipolar I and II disorder, schizophrenia, organic brain syndromes, or other major physical illnesses; 2. Patients who had received or will receive brain surgery or receive brain metal implantation (for example, neurostimulator) or received cardiac pacemakers; 3. Patients who had strong suicidal ideation within one week ( 3 points for third item of HDRS-suicidality) 4. Patients who had abnormal finding in the brain ( for example, brain tumor or arteriovenous malformation) or neurological disease ( for example, history of meningitis, encephalitis, epilepsy, stroke or neurodegenerative disease) 5. Pregnancy; 6. Patients who have metal implantation in the body, including cochlear implant, prosthetic heart valve, neurostimulator, clips.. etc 7. Patients who also failed to respond after receiving one completed course of electroconvulsive therapy (ECT) treatment or left dorsolateral prefrontal brain stimulation (adequate dose and adequate duration of ECT or DLPFC-rTMS and had followed up to monitor the efficacy at least for three months) 8. Claustrophobia for MRI screening; 9. Those who cannot follow the protocols, and did not sign informed consent proved by the institutional review board (IRB)
Where this trial is running
Taipei
- Taipei Veterans General Hospital, Taiwan — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chih-Ming Cheng, M.D. — Taipei Veterans General Hospital, Taiwan
- Study coordinator: Chih-Ming Cheng, M.D.
- Email: vdodaco@gmail.com
- Phone: +886 2 28757027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.