Depression Clinical Trial
Official title:
Pre-treatment Biomarker for Clinical Response to Neuronavigation Repetitive Transcranial Magnetic Stimulation (rTMS) in the Acute Phase Treatment of Refractory Major Depressive Episode- Role of Intrinsic Functional Connectivity
Notwithstanding the cumulative evidence on the safety and efficacy of transcranial magnetic stimulation in depression care, the non-response rate to transcranial magnetic stimulation (TMS) amongst treatment-resistant depression has remained substantial despite the health care cost and time incurred. There remains a compelling clinical need to find valid biomarkers to inform personalized treatment. Using supervised machine learning on 4 combined features of neuroimaging markers, our group recently reported excellent prediction for clinical response in 70 patients receiving TMS to left dorsolateral prefrontal cortex for medication-resistant major depression in 2015-18 (Phase 1 study).The clinical utility of these potential neuroimaging biomarkers is still uncertain without further validation of the trained model in an independent clinical cohort.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - right-handed - meet the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) criteria for major depressive disorder - at least moderate episode or with a score of >20 on Montgomery-asberg Depression Rating Scale (MADRS) and >18 on Hamilton Depression Rating Scale(HDRS) 17-item; - has failed to respond adequately to at least one full course (>6 weeks) of antidepressant medication or medication intolerant. Exclusion Criteria: - significant head trauma - active abuse of alcohol or illegal substances - current psychotic symptoms - suicide ideation/recent suicide attempts - other DSM-IV Axis I and II psychiatric diagnosis - neurological disorders and contraindications to fMRI (e.g. pace makers, metal implants, pregnancy) or rTMS, or having undergone electroconvulsive therapy in the preceding year. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Psychiatry, CUHK | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Ashberg Depression Rating Scale | Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression. | Percentage change baseline versus week 4 | |
Primary | Montgomery-Ashberg Depression Rating Scale | Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression. | Percentage change baseline versus week 6 | |
Primary | Montgomery-Ashberg Depression Rating Scale | Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression. | Percentage change baseline versus week 8 | |
Primary | Montgomery-Ashberg Depression Rating Scale | Questionnaire used to measure the severity of depressive symptoms and treatment response in patients with mood disorders consisting of 10 items. The score range is 0-60 and higher score indicates more severe depression. | Percentage change baseline versus week 12 | |
Secondary | Clinical Global Impression Scale | A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission. | Percentage change baseline versus week 4 | |
Secondary | Clinical Global Impression Scale | A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission. | Percentage change baseline versus week 6 | |
Secondary | Clinical Global Impression Scale | A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission. | Percentage change baseline versus week 8 | |
Secondary | Clinical Global Impression Scale | A 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Score of 2 indicates significant clinical response while score of 1 indicates clinical remission. | Percentage change baseline versus week 12 |
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