Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment (MINDSET)
31. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-post: cip@nuhs.edu.sg
Studiesteder
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Singapore, Singapore
- National University Hospital, Singapore
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Ta kontakt med:
- Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-post: cip@nuhs.edu.sg
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)
Tidsramme: Baseline, and weekly for 12 months.
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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.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
18. august 2026
Først innsendt som oppfylte QC-kriteriene
18. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-0652
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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