A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression
Recruiting · NCT06385223 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Beam F3 targeted accelerated iTBSIndividualized connectome-guided accelerated iTBS
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Institute of Mental Health - Singapore, Singapore