Phase
Condition
Bipolar Disorder
Mood Disorders
Depression (Major/severe)
Treatment
Intensive intermittent theta-burst stimulation (iTBS)
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 depressionwith 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-AsbergDepression Rating Scale (MADRS)
Exclusion
Exclusion Criteria:
No current substance abuse disorder for the past 6 months (previous substance abusenot exclusionary)
Any psychotic disorder or current active psychotic symptoms (personality disordersnot exclusionary unless in the opinion of the referring psychiatrist it wouldjeopardize 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 throughwith the study & must have verified contact information and at least one verifiedcontact
Pregnancy. While there are no known risks to a fetus this is a new use of TMS, whichhas not been tested, thus pregnancy is exclusionary
Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixedfeatures have been shown not to respond well to TMS treatment)
Rapid cycling Bipolar illness (patients with > 4 mood episodes within the past yearwill be excluded, as they have a higher risk of switch to mania)
Any implants, conditions, or contraindications that would be deemed unsafe for TMSor MRI
Currently using benzodiazepines (such as lorazepam) with a dose >1 mg per day orequivalent.
Study Design
Study Description
Connect with a study center
Center for Neuromodulation in Depression and Stress, University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available

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