Status:
UNKNOWN
Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Treatment-resistant Depression
Major Depressive Disorder
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Several open label studies showed the preliminary clinical efficacy of DMPFC stimulation, but there was no randomized sham-control trial to confirm the clinical efficacy in Asian people. In addition, ...
Eligibility Criteria
Inclusion
- 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);
- 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);
- 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);
- 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
- Patients with Bipolar I and II disorder, schizophrenia, organic brain syndromes, or other major physical illnesses;
- Patients who had received or will receive brain surgery or receive brain metal implantation (for example, neurostimulator) or received cardiac pacemakers;
- Patients who had strong suicidal ideation within one week ( 3 points for third item of HDRS-suicidality)
- 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)
- Pregnancy;
- Patients who have metal implantation in the body, including cochlear implant, prosthetic heart valve, neurostimulator, clips.. etc
- 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)
- Claustrophobia for MRI screening;
- Those who cannot follow the protocols, and did not sign informed consent proved by the institutional review board (IRB)
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05422417
Start Date
June 7 2022
End Date
December 31 2025
Last Update
August 17 2022
Active Locations (1)
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1
Taipei Veterans General Hospital, Taiwan
Taipei, Taiwan