Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07779330

Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment

This proposal seeks to carry out a prospective, single-arm open label study aimed at sustaining treatment-resistant depression (TRD) response in patients with TRD who had responded to prior individualized resting-state functional connectivity (rs-FC)-guided intermittent theta burst stimulation (iTBS). It also seeks to detect and predict relapse risk by integrating rs-FC iTBS with a TMS-adapted needs-based symptom-titrated algorithm based longitudinal ECT (STABLE) maintenance scheduling algorithm, and passive digital biomarkers.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Depression Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Disease Attributes Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

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 to ≤ 70 years old
  • Able to give informed consent
  • Able to understand English
  • DSM-V diagnosis of current/ past major depressive disorder (MDD) episode
  • Non-response to an adequate trial (4 weeks) of at least 1 MDD medication as verified by a study clinician
  • Ability to comply with passive wearable use and weekly mobile assessments
  • Have previously completed a course of individualized, functional connectivity-guided accelerated iTBS and shown a clinical response (as defined by a ≥50% improvement in MADRS score against baseline, any time within 3 months following an acute iTBS course)
  • Able to comply with the full 12-month protocol inclusive of continuous digital monitoring

Exclusion criteria

  • DSM-5 psychotic disorder
  • Drug or alcohol abuse or dependence (preceding 3 months)
  • Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
  • Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices
  • Tattoos containing ferromagnetic ink or permanent piercings
  • Pregnancy
  • Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses)
  • Participant does not have the capacity to provide consent

Treatment and study plan

Individualized resting-state functional connectivity-guided iTBS

Device

MagPro X100, Axilium Cobot, Localite Camera

Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm

Diagnostic Test

The STABLE relapse detection algorithm provides a symptom-driven retreatment scheduling. It is validated to prolong TRD response to electroconvulsive therapy (ECT) while minimizing overtreatment. The algorithm will be adapted for TMS and will be used to determine the need for maintenance iTBS treatment.

Primary outcomes

  1. Percentage of time spent in response

    Time frame: Baseline, and weekly for 12 months.

    The investigators will compute the percentage of time spent in TRD response over the course of each participant's time in the study. TRD response is defined by fulfilling the low relapse criteria in accordance with the STABLE algorithm. In this study, low relapse potential would be a MADRS score of ≤9 or a MADRS score of 10-19 with <3-point increase from baseline, and <5-point increase in 4 consecutive weeks at any point in the study.

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)

    Time frame: Baseline, and weekly for 12 months.

    QIDS-SR16 is an ordinal self-report scale measuring depressive symptomatology ranging from 0-27. Higher scores mean a worse outcome.

  2. Beck Anxiety Index (BAI)

    Time frame: Baseline, and weekly for 12 months.

    BAI is an ordinal self-report scale measuring cognitive and physical anxiety symptoms ranging from 0-63. Higher scores mean a worse outcome.

  3. General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, and weekly for 12 months.

    GAD-7 is an ordinal self-report scale measuring general anxiety ranging from 0-21. Higher scores mean a worse outcome.

  4. EuroQol 5-Dimension (EQ-5D)

    Time frame: Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months.

    EQ-5D is an ordinal self-report scale measuring the health-related quality of life graded across severity levels. It includes a Visual Analogue Scale (VAS), which ranges from 0-100, with a higher score meaning a better outcome.

  5. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)

    Time frame: Baseline, and weekly for 12 months.

    Q-LES-Q-SF is an ordinal self-report scale measuring satisfaction with daily life and functioning, ranging from 0-70. Higher scores mean a better outcome.

  6. Sheehan Disability Scale (SDS)

    Time frame: Baseline, and weekly for 12 months.

    SDS is an ordinal self-report scale measuring how symptoms affect functional impairment across work/ school, social life, and family/ home responsibilities, ranging from 0-10 for each domain. Higher scores mean a worse outcome.

  7. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: Baseline, and weekly for 12 months.

    MADRS is an ordinal clinician-rated scale measuring depression ranging from 0-60. Higher scores mean a worse outcome.

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

Official study title

MINDSET: Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment

Acronym: MINDSET

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 21, 2026
Registry last updated
Aug 21, 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.

Related clinical trials

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