Mapping the Neural Circuits of Depression and Anxiety Using Personalized, Accelerated TMS and Deep Phenotyping (ADAPT)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Phern Chern Tor, MBBS
- Telefonnummer: +65 6908 2222
- E-mail: cip@nuhs.edu.sg
Studiesteder
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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
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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. |
Magpro X100, Axilium Cobot, Localite Camera
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Eksperimentel: 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. |
Magpro X100, Axilium Cobot, Localite Camera
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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.).
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symtpoms ranging from 99-495.
Higher scores mean worse outcome.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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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.
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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.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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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.
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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.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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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.
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The investigators will also perform additional exploratory post-hoc analyses by analysing passive physiological data collected using an Oura ring throughout the study duration.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-1315
Plan for individuelle deltagerdata (IPD)
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