Status:
SUSPENDED
Enhanced Spatial Targeting in ECT Utilizing FEAST
Lead Sponsor:
University of Minnesota
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
22-90 years
Phase:
NA
Brief Summary
The purpose of this research study is to find an alternative version of ECT that reduces the negative side effects (mainly memory loss) while still providing patients with relief from depressive sympt...
Detailed Description
Study Design: This study will focus on refining FEAST methods by implementing a fixed-current titration and dosing method (800mA; 0.3 ms), testing the optimal directionality of current flow, and confi...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder using MINI-7 to derive RDC; DSM-IV
- Pretreatment HRSD score greater than or equal to 18
- ECT indicated by physician evaluation
- Willing and capable of providing informed consent as determined by physician evaluation
Exclusion
- History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by MINI-7; rapid cycling defined as greater than or equal to four episodes in past year
- History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history
- Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation
- Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation
- Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation
- ECT in the past six months determined by physician evaluation and medical history
- Pregnancy as determined by urine pregnancy test and clinical interview
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04099342
Start Date
April 1 2022
End Date
June 30 2026
Last Update
October 31 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455