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Mapping the Neural Circuits of Depression and Anxiety Using Personalized, Accelerated TMS and Deep Phenotyping (ADAPT)

13. august 2026 oppdatert av: National University Hospital, Singapore
This proposal seeks to carry out a double-blinded, randomized, comparative study that investigates neurobehavioral changes induced by personalized, anxiosomatic and dysphoric network guided accelerated intermittent-theta burst (iTBS) using dense functional Magnetic Resonance Imaging (fMRI) sampling in participants with treatment-resistant depression (TRD) and moderate/high levels of anxiety.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

36

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

  • Singapore
      • Singapore, Singapore
        • National University Hospital, Singapore
        • Ta kontakt med:
          • Phern Chern Tor, MBBS
          • Telefonnummer: +65 6908 2222
          • E-post: cip@nuhs.edu.sg

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 21-70
  • Diagnosis of MDD as validated by MINI
  • Non-response to adequate trial (4 weeks) of at least two MDD medication as verified by the study clinician
  • BDI score of 20 or above; BAI score of 16 or above
  • Able to give informed consent
  • Able to understand English

Exclusion Criteria:

  • DSM-5 psychotic disorder
  • Drug or alcohol abuse or dependence (preceding 3 months)
  • Rapid clinical response required, e.g., high suicide risk
  • Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
  • Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device
  • Pregnancy
  • Unsuitable for MRI
  • With recent TMS or ECT treatment in past 3 months
  • Multiple stimulant medications

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dysphoric target

Participants will receive individualized connectome-guided accelerated iTBS at their dysphoric target.

Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterflu shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 6 treatment sessions daily for 5 consecutive workdays for a total of 30 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50Hz, repeated at 5Hz; 2s on and 8s off; 1800 puolses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.
Enhet: Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite Camera
Eksperimentell: Anxiosomatic target

Participants will receive individualized connectome-guided accelerated iTBS at their anxiosomatic target.

Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterflu shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 6 treatment sessions daily for 5 consecutive workdays for a total of 30 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50Hz, repeated at 5Hz; 2s on and 8s off; 1800 puolses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.
Enhet: Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite Camera

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change
Tidsramme: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
The primary outcome will be the rank-transformed ratio of BDI change to BAI change (e.g. A patient has a 50% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 50% ÷ 25% = 2.0. Another patient has a 40% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 40% ÷ 25% = 1.6. Higher ratios indicate a relatively greater improvement in depression compared with anxiety within each patient. This ratio is then ranked across all patients.).
Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
Tidsramme: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symtpoms ranging from 99-495. Higher scores mean worse outcome.
Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
Penn State Worry Questionnaire (PSWQ)
Tidsramme: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80. Scores depend on whether the item is worded positively or negatively.
Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
Interaction between TMS target and change in BDI and BAI
Tidsramme: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
The investigators will test interactions between TMS Target and change in BDI and BAI (including baseline and weekly outcomes over one month) separately using repeated measures linear mixed effects models.
Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
TMS induced changes in resting-fMRI functional connectivity
Tidsramme: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
Passive physiological metrics
Tidsramme: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
The investigators will also perform additional exploratory post-hoc analyses by analysing passive physiological data collected using an Oura ring throughout the study duration.
Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National University Hospital, Singapore

Samarbeidspartnere

National University of Singapore

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)

31. juli 2029

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

2. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-1315

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

produkt produsert i og eksportert fra USA

Nei

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