Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment

N/ANot Yet RecruitingNCT07779330

National University Hospital, Singapore24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression Disorder

Interventions

Individualized resting-state functional connectivity-guided iTBS

Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithmDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.