RecruitingNot ApplicableNCT03348761

rTMS Response Trajectories in Depression

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


Sponsor

Chinese University of Hong Kong

Enrollment

70 participants

Start Date

Aug 4, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

Interventions

DEVICErTMS group

Locations(1)

Department of Psychiatry, CUHK

Hong Kong, Hong Kong

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03348761


Related Trials