Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm: The 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
21 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Non-response to an adequate trial (4 weeks) of at least 1 MDD medication as verified by a study clinician
* Ability to comply with passive wearable use and weekly mobile assessments
* Have previously completed a course of individualized, functional connectivity-guided accelerated iTBS and shown a clinical response (as defined by a ≥50% improvement in MADRS score against baseline, any time within 3 months following an acute iTBS course)
* Able to comply with the full 12-month protocol inclusive of continuous digital monitoring
Exclusion Criteria:
* 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
* Tattoos containing ferromagnetic ink or permanent piercings
* Pregnancy
* Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses)
* Participant does not have the capacity to provide consent
Primary outcome measure(s)
Percentage of time spent in response — Baseline, and weekly for 12 months. 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.
Trial sites (1)
Facility
City
Region
Status
National University Hospital, Singapore
Singapore
Singapore
More National University Hospital, Singapore trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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