Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06385223

A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression

The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

21 year and older

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

  • Age ≥ 21 years.
  • DSM-5 diagnosis of current Major Depressive Episode.
  • Montgomery-Asberg Depression Rating Scale score of 20 or more.
  • Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
  • Able to give informed consent.

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.

Treatment and study plan

Beam F3 targeted accelerated iTBS

Device

Magpro X100, Axilium Cobot, Localite camera

Individualized connectome-guided accelerated iTBS

Device

Magpro X100, Axilium Cobot, Localite camera

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale

    Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention

    Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)

    Time frame: Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention

    Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention

    global cognitive functioning, scored 0-30, higher score means better outcome

  3. EQ-5D (EuroQol)

    Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention

    Quality of life scales, scored 0-100, higher scores mean better outcome

  4. Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)

    Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention

    Quality of life scales, scored 14-70, higher score means better outcome

Other outcomes

  1. TMS induced changes in resting-fMRI functional connectivity

    Time frame: Baseline, immediately post treatment

    The investigators will also perform additional exploratory posthoc analyses by analysing brain imaging changes before and after TMS

Study contacts

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

Phern Chern Tor, MBBS

CONTACT

[email protected]

63892000

Sponsors and collaborators

Lead sponsor

Institute of Mental Health, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Official study title

A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Aug 1, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.