Depression DisorderMINDSETNCT07779330
Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment
A study testing Individualized resting-state functional connectivity-guided iTBS and Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm in people with Depression Disorder, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Depression Disorder
- What is being tested?
- Individualized resting-state functional connectivity-guided iTBS and Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2026to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Hospital, Singapore
Singapore
Phern Chern Tor, MBBS, +65 6908 2222, cip@nuhs.edu.sg
About this study
Official title: MINDSET: Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early 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.
- Conditions
- Depression Disorder
- Being tested
- Individualized resting-state functional connectivity-guided iTBS, Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm
- Keywords
- Depression, iTBS, Neuronavigated, Maintenance, Relapse, Treatment resistant depression
- Medical subject headings
- Depression, Recurrence, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized resting-state functional connectivity-guided iTBSDevice
MagPro X100, Axilium Cobot, Localite Camera
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized, resting-state functional connectivity-guided accelerated iTBS | Experimental | Not described Receives: Device: Individualized resting-state functional connectivity-guided iTBS; Diagnostic Test: Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and weekly for 12 months.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, and weekly for 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779330
- Sponsor's protocol ID
- 2026-0652
- Acronym
- MINDSET
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No