Mapping the Neural Circuits of Depression and Anxiety Using Personalized, Accelerated TMS and Deep Phenotyping
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care provider, Outcomes assessor)
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Individualized connectome-guided accelerated iTBS (Device)
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.
Intervention: Individualized connectome-guided accelerated iTBS (Device)
Outcomes
Primary Outcomes
Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change
Time Frame: 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.).
Secondary Outcomes
- Inventory of Depression and Anxiety Symptoms-II (IDAS-II)(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)(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(Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.)
Investigators
Study Sites (1)
Identifiers
- NCT ID
- NCT07766291
- Other Study IDs
- 2025-1315
Dates
- First Submitted
- (3 months ago)
- First Posted
- (last month)
- Primary Completion
- (in 2 years)
- Study Completion
- (in 3 years)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No