Status:
COMPLETED
Intensive TMS for Bipolar Depression
Lead Sponsor:
University of Pennsylvania
Conditions:
Bipolar Depression
Treatment Resistant 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 transcranial magnetic stimulation) produces a significant reduction in depressive symptoms comp...
Detailed Description
The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms comp...
Eligibility Criteria
Inclusion
- Bipolar depression (BP I and BP II) by Diagnostic and Statistical Manual 5 (DSM 5) criteria
- 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
- 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 Montgomery-Asberg Depression Rating Scale (MADRS)
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 Young Mania Rating Scale (YMRS) greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment)
- 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)
- Any implants, conditions, or contraindications that would be deemed unsafe for TMS or MRI
- Currently using benzodiazepines (such as lorazepam) with a dose \>1 mg per day or equivalent.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05228457
Start Date
March 1 2022
End Date
February 19 2024
Last Update
March 12 2025
Active Locations (1)
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1
Center for Neuromodulation in Depression and Stress, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104