This proposal seeks to carry out a prospective, single-arm open label study aimed at sustaining treatment-resistant depression (TRD) response in patients with TRD who had responded to prior individualized resting-state functional connectivity (rs-FC)-guided intermittent theta burst stimulation (iTBS). It also seeks to detect and predict relapse risk by integrating rs-FC iTBS with a TMS-adapted needs-based symptom-titrated algorithm based longitudinal ECT (STABLE) maintenance scheduling algorithm, and passive digital biomarkers.
Male/ female aged ≥ 21 to ≤ 70 years old
Able to give informed consent
Able to understand English
DSM-V diagnosis of current/ past major depressive disorder (MDD) episode
DSM-5 psychotic disorder
Drug or alcohol abuse or dependence (preceding 3 months)
Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices
Single group
Individualized resting-state functional connectivity-guided iTBS
DeviceMagPro X100, Axilium Cobot, Localite Camera
Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm
Diagnostic testThe STABLE relapse detection algorithm provides a symptom-driven retreatment scheduling. It is validated to prolong TRD response to electroconvulsive therapy (ECT) while minimizing overtreatment. The algorithm will be adapted for TMS and will be used to determine the need for maintenance iTBS treatment.
Percentage of time spent in response
The investigators will compute the percentage of time spent in treatment-resistant depression (TRD) response over the course of each participant's time in the study. TRD response is defined by fulfilling the low relapse criteria in accordance with the (symptom-titrated algorithm-based longitudinal ECT) STABLE algorithm. In this study, low relapse potential would be a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≤9 or a MADRS score of 10-19 with \<3-point increase from baseline, and \<5-point increase in 4 consecutive weeks at any point in the study. MADRS is an ordinal clinician-rated scale measuring depression ranging from 0-60. Higher scores mean a worse outcome.
Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)
QIDS-SR16 is an ordinal self-report scale measuring depressive symptomatology ranging from 0-27. Higher scores mean a worse outcome.
Beck Anxiety Index (BAI)
BAI is an ordinal self-report scale measuring cognitive and physical anxiety symptoms ranging from 0-63. Higher scores mean a worse outcome.
General Anxiety Disorder-7 (GAD-7)
GAD-7 is an ordinal self-report scale measuring general anxiety ranging from 0-21. Higher scores mean a worse outcome.
EuroQol 5-Dimension (EQ-5D)
EQ-5D is an ordinal self-report scale measuring the health-related quality of life graded across severity levels. It includes a Visual Analogue Scale (VAS), which ranges from 0-100, with a higher score meaning a better outcome.
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National University Hospital, Singapore
Lead sponsor
National University of Singapore
Collaborator
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