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NCT07779330Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
24 (estimated)
First submitted
18 Aug 2026
Start date
Sept 2026
Primary completion date
Sept 2028
Lead sponsor
National University Hospital, Singapore
Diseases
Depression
NCT number
NCT07779330

What you commit to

  • Study type: Interventional
  • Planned participants: 24
  • From Sept 2026 to the primary completion date, Sept 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Drug or alcohol abuse or dependence (preceding 3 months)
  • Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices
  • Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses)

Other illness

  • DSM-5 psychotic disorder
  • Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy

Other

  • Tattoos containing ferromagnetic ink or permanent piercings
  • Pregnancy
  • Participant does not have the capacity to provide consent

Who the study is looking for

  • 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

Age in the registry: 21 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National University Hospital Singapore
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.