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NCT Number: NCT07766291

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

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.

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Key information

Conditions

Depression Disorder Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized connectome-guided accelerated iTBS

Device

Magpro X100, Axilium Cobot, Localite Camera

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Penn State Worry Questionnaire (PSWQ)

    Time frame: 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.

  3. Interaction between TMS target and change in BDI and BAI

    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 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.

Other outcomes

  1. TMS induced changes in resting-fMRI functional connectivity

    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 investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.

  2. Passive physiological metrics

    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 investigators will also perform additional exploratory post-hoc analyses by analysing passive physiological data collected using an Oura ring throughout the study duration.

Study contacts

Contact information is provided by the study sponsor or research team.

Phern Chern Tor, MBBS

CONTACT

[email protected]

+65 6908 2222

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Acronym: ADAPT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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