A Phase 3 interventional study of spectrum 5000Q ECT device (RUL ECT) and spectrum 5000Q ECT device (RUL LAP ECT) in Depression, sponsored by Augusta University. Completed at 1 site in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Augusta University · Phase 3, Interventional, and Treatment
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.
Lower amplitude ECT (LAP) has been shown to induce seizures of adequate duration in a single titration session. This current study is hypothesized to increase stimulation focality, thus hypothetically minimizing cognitive side effects.
The central hypothesis is that LAP has significantly less cognitive adverse effects compared to conventional Right Unilateral (RUL) ECT.
The study will enroll 10 patients recruited from Medical College of Georgia. Patients referred to ECT service in the Medical College of Georgia usually occurs from clinical services and private physicians and the study will recruit patients who are clinically indicated to do ECT. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 11 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Right Unilateral LAP ECT
Device: spectrum 5000Q ECT device (RUL LAP ECT)
standard Right Unilateral ECT
Device: spectrum 5000Q ECT device (RUL ECT)
Memory (cognitive side effects)
Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Time to reorientation
Measured by Time to Orientation Test (TRO, primary outcome)
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Resilience
Connor-Davidson Resilience Scale
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Suicidal Ideation
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Depression
used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Depression
Patient Health Questionnaire (PHQ 9)
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Trauma symptoms
PTSD Checklist
Time frame: From Baseline to end of acute course (typically after 4 weeks)
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Augusta University