The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
Age ≥ 21 years.
DSM-5 diagnosis of current Major Depressive Episode.
Montgomery-Asberg Depression Rating Scale score of 20 or more.
Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
DSM-5 psychotic disorder
Drug or alcohol abuse or dependence (preceding 3 months).
Rapid clinical response required, e.g., high suicide risk.
Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
Parallel
Beam F3 targeted accelerated iTBS
DeviceMagpro X100, Axilium Cobot, Localite camera
Individualized connectome-guided accelerated iTBS
DeviceMagpro X100, Axilium Cobot, Localite camera
Montgomery-Åsberg Depression Rating Scale
Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome
Montreal Cognitive Assessment (MoCA)
global cognitive functioning, scored 0-30, higher score means better outcome
EQ-5D (EuroQol)
Quality of life scales, scored 0-100, higher scores mean better outcome
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)
Quality of life scales, scored 14-70, higher score means better outcome
TMS induced changes in resting-fMRI functional connectivity
The investigators will also perform additional exploratory posthoc analyses by analysing brain imaging changes before and after TMS
Click on the lead sponsor to view all of their trials.
Institute of Mental Health, Singapore
Lead sponsor
National University of Singapore
Collaborator
