Enhancing iTBS for treating depression
Frequency and E-field Enhancement of ITBS for Depression (FREED)
This study tests if a personalized brain stimulation treatment can help people with treatment-resistant depression feel better compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT06003309 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of individualized intermittent Theta Burst Stimulation (iTBS) for patients with treatment-resistant depression (TRD). It involves a randomized, double-blinded design with three treatment arms: fully individualized iTBS, targeted iTBS, and standard iTBS. Over 20 sessions in four weeks, the study will assess changes in brain connectivity and clinical depression severity using EEG and standardized rating scales. The goal is to determine if the individualized approach leads to better outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of major depressive disorder who have not responded to at least one antidepressant medication.
Not a fit: Patients with active psychotic symptoms, neurological disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from treatment-resistant depression.
How similar studies have performed: Other studies have shown promise with similar approaches to individualized brain stimulation, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder disorder. * 18-80 years of age. * Male or female. * At least one failed antidepressant medication trial at level 3 in the Antidepressant Treatment History Form: Short Form (ATHF-SF) classification. * Montgomery-Asberg Depression Rating Scale (MADRS) Score of \>19 (moderate - severe depression). * No increase or initiation of new antidepressant therapy in the four weeks prior to screening. * Demonstrated capacity to give informed consent. Exclusion Criteria: * Inability to provide informed consent. * Medically unstable patients. * Concomitant neurological disorder or a history of a seizure disorder. * Patients who are pregnant or breastfeeding. * Any psychotic disorder or current active psychotic symptoms. * Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS. * Contraindication to MRI scanning.
Where this trial is running
La Jolla, California and 1 other locations
- University of California, San Diego — La Jolla, California, United States (Recruiting)
- Australian National University — Canberra, Australia (Recruiting)
Study contacts
- Study coordinator: Interventional Psychiatry
- Email: iptrials@health.ucsd.edu
- Phone: 858-207-0938
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.