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

N/ANot Yet RecruitingNCT07766291

National University Hospital, Singapore36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Depression Disorder

Interventions

Individualized connectome-guided accelerated iTBSDEVICE

Magpro X100, Axilium Cobot, Localite Camera

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

National University Hospital, Singapore

Singapore, Singapore

Outcomes

Primary Outcomes

Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change

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.).

Time frame: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.

Secondary Outcomes

Inventory of Depression and Anxiety Symptoms-II (IDAS-II)

IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symtpoms ranging from 99-495. Higher scores mean worse outcome.

Time frame: 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)

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.

Time frame: 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

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.

Time frame: Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.

Central Contacts

Phern Chern Tor, MBBS

CONTACT

+65 6908 2222 cip@nuhs.edu.sg

Data from ClinicalTrials.gov

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