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

Not Applicable

Recruiting

• Conditions: Depression

• Registration Number: NCT06385223
• Lead Sponsor: Institute of Mental Health, Singapore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-25
• Status Verified: 2024-06
• Study Start: 2024-07-01
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

1. DSM-5 psychotic disorder
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Rapid clinical response required, e.g., high suicide risk.
4. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
5. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
6. Pregnancy.
7. Unsuitable for MRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale	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 Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)	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
EQ-5D (EuroQol)	Baseline, immediately post treatment, 1 month and 3 months post intervention	Quality of life scales, scored 0-100, higher scores mean better outcome
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)	Baseline, immediately post treatment, 1 month and 3 months post intervention	Quality of life scales, scored 14-70, higher score means better outcome
Montreal Cognitive Assessment (MoCA)	Baseline, immediately post treatment, 1 month and 3 months post intervention	global cognitive functioning, scored 0-30, higher score means better outcome

Trial Locations

Locations (1)

Institute of Mental Health; 🇸🇬 Singapore, Singapore