An interventional study of Individualized resting-state functional connectivity-guided iTBS and Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm in Depression Disorder, sponsored by National University Hospital, Singapore. Not yet recruiting at 1 site in Singapore. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 24 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Individualized resting-state functional connectivity-guided iTBS · Diagnostic Test: Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm
MagPro X100, Axilium Cobot, Localite Camera
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.
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.
Time frame: Baseline, and weekly for 12 months.
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.
Time frame: Baseline, and weekly for 12 months.
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.
Time frame: Baseline, and weekly for 12 months.
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.
Time frame: Baseline, and weekly for 12 months.
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.
Time frame: Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months.
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
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.
Time frame: Baseline, and weekly for 12 months.
Sheehan Disability Scale (SDS)
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.
Time frame: Baseline, and weekly for 12 months.
Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is an ordinal clinician-rated scale measuring depression ranging from 0-60. Higher scores mean a worse outcome.
Time frame: Baseline, and weekly for 12 months.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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