Status:
ACTIVE_NOT_RECRUITING
Bipolar Efficacy Biomarkers for rTMS
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
University of Pennsylvania
Milken Institute
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of repetitive transcranial magnetic stimulation) produces a significant reduction in depressive sy...
Eligibility Criteria
Inclusion
- Bipolar depression (BP I and BP II) by DSM 5 criteria (Diagnostic and Statistical Manual of Mental Disorders, 2013)
- Age 18-70
- Right or left handed
- All genders
- Treatment resistant depression, as in they must have treatment resistant depression with 2 or more prior antidepressant trials that have failed to produce a response (\> 50% reduction in symptoms) using ATHF criteria (Sackeim et al., 2019)
- Able to provide informed consent to participate in the study
- Must be on a stable medication regimen, requiring at least one mood stabilizer
- Depression severity as represented by scoring at least 20 on MADRS
- Meet the safety criteria as defined in the transcranial magnetic stimulation adult safety screen (TASS).
Exclusion
- No current substance abuse disorder for the past 6 months (previous substance abuse not exclusionary)
- Any psychotic disorder or current active psychotic symptoms (personality disorders not exclusionary unless in the opinion of the referring psychiatrist it would jeopardize participation)
- No dementia or other major neurological disorders
- Not having depression as primary disorder
- No major medical illness, for example metastatic cancer, end stage renal disease
- Not able to verify contact information. Participants must be able to follow through with the study \& must have verified contact information and at least one verified contact
- Pregnancy. While there are no known risks to a fetus this is a new use of TMS, which has not been tested, thus pregnancy is exclusionary
- Score on YMRS greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment (Tavares et al., 2021).
- Rapid cycling Bipolar illness (patients with \> 4 mood episodes within the past year will be excluded, as they have a higher risk of switch to mania (Tondo et al., 2010)
- Any implants, conditions, or contraindications that would be deemed unsafe for TMS or MRI
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05393648
Start Date
July 5 2022
End Date
December 31 2025
Last Update
March 4 2024
Active Locations (1)
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1
UCSD Interventional Psychiatry
San Diego, California, United States, 92127