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NCT02535572 · ClinicalTrials.gov registry record · Phase 2
Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT02535572 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 48 participants.
The verdict
NCT02535572, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This open label investigation further evaluates the safety, efficacy and potential mechanisms of action of a new form of electroconvulsive therapy (ECT). The investigators have recently completed preliminary open-label studies with FEAST, first at Columbia University, and then at the Medical University of South Carolina in Charleston (Nahas et al., 2013b). The investigators have published the outcomes of the first 17 patients studied. One patient withdrew from the study after a single titration session. After the course of FEAST (median 10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale for Depression (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P \< 0.0001). Eight of 16 patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission criteria (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 + 6.4 min (median time = 3.6 min), timed from when their eyes first opened after treatment. The investigators have now studied 18 more patients (see results below), and we are completing the study in the original IDE with another two more patients still to enroll. This work allowed us to refine the treatment. For example, the investigators selectively modified the electrode geometry to decrease interelectrode resistance. Additionally the investigators modified the titration schedule, now only administering a standard 800 ma ultrabrief pulse, and thus no longer titrating in the current domain. In this next proposed trial we will continue to gather efficacy and safety data, and compare these to a parallel non-randomized group receiving ECT standard of care. ECT is typically delivered in a dynamically adaptive manner, with each person having a different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus have to use imprecise time points such as 'at the end of the acute treatment course' rather than specified dates or visits.
Interventions
- DEVICE FEAST
- DEVICE RUL UB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-06-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02535572
The ClinicalTrials.gov registry entry for NCT02535572 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FEAST is the first listed.
NCT02535572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02535572 about?
NCT02535572 is a clinical study titled "Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment". This open label investigation further evaluates the safety, efficacy and potential mechanisms of action of a new form of electroconvulsive therapy (ECT). The investigators have recently completed preliminary open-label studies with FEAST, first at Columbia University, and then at the Medical Univers...
What is the current status of trial NCT02535572?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2015-08. Estimated completion is 2019-06-10.
What interventions are being tested in trial NCT02535572?
The interventions under investigation include: FEAST (DEVICE), RUL UB (DEVICE).
Who is sponsoring clinical trial NCT02535572?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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