Status:
RECRUITING
Frequency and E-field Enhancement of ITBS for Depression (FREED)
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Indivi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06003309
Start Date
August 31 2023
End Date
April 1 2025
Last Update
March 1 2024
Active Locations (2)
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1
University of California, San Diego
La Jolla, California, United States, 92093
2
Australian National University
Canberra, Australia, 2601