Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment (MINDSET)
31 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-post: cip@nuhs.edu.sg
Studieorter
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Singapore, Singapore
- National University Hospital, Singapore
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Kontakt:
- Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-post: cip@nuhs.edu.sg
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of time spent in response
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2028
Avslutad studie (Beräknad)
1 december 2029
Studieregistreringsdatum
Först inskickad
18 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 augusti 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-0652
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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