Individualized brain stimulation approach for treating depression
A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial
This study is testing a personalized brain stimulation method to see if it helps people with depression who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Institute of Mental Health, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06385223 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an individualized connectome-guided approach to accelerated intermittent theta burst stimulation (iTBS) compared to a standard anatomically-guided method for patients with depression. The study will involve a randomized, double-blind design, recruiting both inpatients and outpatients who have not adequately responded to previous antidepressant treatments. Participants will undergo targeted brain stimulation to assess improvements in their depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with a current diagnosis of Major Depressive Episode and insufficient response to prior antidepressant medication.
Not a fit: Patients with psychotic disorders, substance abuse issues, or those requiring immediate clinical intervention due to high suicide risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients suffering from depression who have not responded to traditional therapies.
How similar studies have performed: While the approach is innovative, similar studies using targeted brain stimulation techniques have shown promise in treating depression, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore
- Institute of Mental Health — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Phern Chern Tor, MBBS
- Email: phern_chern_tor@imh.com.sg
- Phone: 63892000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.