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

Registry ID
NCT07766291
Source registry
NCT
Status
NOT_YET_RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
National University Hospital, Singapore
Enrollment
36
Start date
2026-09-01
Completion date
2029-12-31
Last update
2026-08-14

Conditions

Summary

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.

Interventions

Inclusion criteria

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

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

Primary outcomes

[{"measure":"Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change","timeFrame":"Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period."}]

Locations

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