Depression Disorder
Conditions
Keywords
Depression, iTBS, Neuronavigated, Maintenance, Relapse, Treatment resistant depression
Brief 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.
Interventions
DEVICEIndividualized resting-state functional connectivity-guided iTBS
MagPro X100, Axilium Cobot, Localite Camera
DIAGNOSTIC_TESTSymptom-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.
Sponsors
National University Hospital, Singapore
National University of Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16) | Baseline, and weekly for 12 months. | 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) | Baseline, and weekly for 12 months. | 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) | Baseline, and weekly for 12 months. | 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) | Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months. | 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. |
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) | Baseline, and weekly for 12 months. | Q-LES-Q-SF is an ordinal self-report scale measuring satisfaction with daily life and functioning, ranging from 0-70. Higher scores mean a better outcome. |
| Sheehan Disability Scale (SDS) | Baseline, and weekly for 12 months. | SDS is an ordinal self-report scale measuring how symptoms affect functional impairment across work/ school, social life, and family/ home responsibilities, ranging from 0-10 for each domain. Higher scores mean a worse outcome. |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline, and weekly for 12 months. | MADRS is an ordinal clinician-rated scale measuring depression ranging from 0-60. Higher scores mean a worse outcome. |
Countries
Singapore
Contacts
CONTACTPhern Chern Tor, MBBS
Outcome results
None listed