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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385223
• Other study ID #: DSRB 2023/00680
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Institute of Mental Health, Singapore
• Contact: Phern Chern Tor, MBBS
• Phone: 63892000
• Email: phern_chern_tor[@]imh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Beam F3 targeted accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
• Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Mental Health, Singapore	National University of Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TMS induced changes in resting-fMRI functional connectivity	The investigators will also perform additional exploratory posthoc analyses by analysing brain imaging changes before and after TMS	Baseline, immediately post treatment
Primary	Montgomery-Åsberg Depression Rating Scale	Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary	Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)	Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome	Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention
Secondary	Montreal Cognitive Assessment (MoCA)	global cognitive functioning, scored 0-30, higher score means better outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary	EQ-5D (EuroQol)	Quality of life scales, scored 0-100, higher scores mean better outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)	Quality of life scales, scored 14-70, higher score means better outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention