rTMS Response Trajectories in Depression
Recruiting · NCT03348761 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Department of Psychiatry, CUHK - Hong Kong, Hong Kong