Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment (MINDSET)
31. august 2026 opdateret af: National University Hospital, Singapore
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-mail: cip@nuhs.edu.sg
Studiesteder
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-
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Singapore, Singapore
- National University Hospital, Singapore
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Kontakt:
- Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-mail: cip@nuhs.edu.sg
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Individualized, resting-state functional connectivity-guided accelerated iTBS
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of time spent in response
Tidsramme: Baseline, and weekly for 12 months.
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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.
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Baseline, and weekly for 12 months.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)
Tidsramme: 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.
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Baseline, and weekly for 12 months.
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Beck Anxiety Index (BAI)
Tidsramme: Baseline, and weekly for 12 months.
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BAI is an ordinal self-report scale measuring cognitive and physical anxiety symptoms ranging from 0-63.
Higher scores mean a worse outcome.
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Baseline, and weekly for 12 months.
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General Anxiety Disorder-7 (GAD-7)
Tidsramme: Baseline, and weekly for 12 months.
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GAD-7 is an ordinal self-report scale measuring general anxiety ranging from 0-21.
Higher scores mean a worse outcome.
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Baseline, and weekly for 12 months.
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EuroQol 5-Dimension (EQ-5D)
Tidsramme: Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months.
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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.
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Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months.
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Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Tidsramme: Baseline, and weekly for 12 months.
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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.
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Baseline, and weekly for 12 months.
|
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Sheehan Disability Scale (SDS)
Tidsramme: Baseline, and weekly for 12 months.
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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.
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Baseline, and weekly for 12 months.
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Montgomery-Åsberg Depression Rating Scale (MADRS)
Tidsramme: Baseline, and weekly for 12 months.
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MADRS is an ordinal clinician-rated scale measuring depression ranging from 0-60.
Higher scores mean a worse outcome.
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Baseline, and weekly for 12 months.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2028
Studieafslutning (Anslået)
1. december 2029
Datoer for studieregistrering
Først indsendt
18. august 2026
Først indsendt, der opfyldte QC-kriterier
18. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-0652
Plan for individuelle deltagerdata (IPD)
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