Low Pulse Amplitude Focal ECT (LAP Study)
NCT02583490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2019-06-20
Summary
This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality. The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.
Conditions
Interventions
- DEVICE
-
spectrum 5000Q ECT device (RUL ECT)
- DEVICE
-
spectrum 5000Q ECT device (RUL LAP ECT)
Sponsors & Collaborators
-
Augusta University
lead OTHER
Principal Investigators
-
Nagy Youssef, MD · Augusta University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- United States
Study Locations
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