Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment

NCT02535572 | Completed Phase 2 Results FDA Device

• 1 other identifier: Pro00042678
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression

Keywords

Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (3)

• Percentage Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression

  The 24-item Hamilton Rating Scale for Depression has a range score of 0-7 (no depression) 7-17(mild depression) 17-24 (moderate depression) 25 and higher (severe depression). The Hamilton Rating Scale for Depression has a range of 0-72. Lower score represents mild depression to no depression at all. A score of 21 or higher for clinical depression (inclusion criteria to participate in study).

  From Baseline to end of acute course (typically after 4 weeks)

• Time to Return to Orientation

  Acute and subacute cognitive side effects following FEAST will be assessed with a brief neuropsychological battery. The primary acute measures will be the time to return of orientation following seizure induction. The neuropsychological measures will be compared in the patients treated with the FEAST methodology (under this IDE) and matched (but nonrandomized) patients who are treated with conventional ECT methods (also covered under this IDE).

  From Baseline to end of the acute course (typically after 4 weeks)

• Retrograde Amnesia for Autobiographical Information Using CUAMI-SF Consistency Scores

  Columbia University Autobiographical Memory Interview (CUAMI-SF) assesses the percent consistency in responses and has a maximum of 100%, with lower percentages representing increasing inconsistency. In this interview subjects receive points for each question they answer at Baseline and again at study follow-up, and are graded on the consistency of their answers.

  4 weeks

Secondary Outcomes (1)

• Number of Adverse Events

  From the start of the study through the six month follow up

Study Arms (2)

FEAST

EXPERIMENTAL

Patients will receive the FEAST form of ECT

Device: FEAST

RUL UB

ACTIVE COMPARATOR

Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB)

Device: RUL UB

Interventions

FEAST DEVICE

FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.

FEAST

RUL UB DEVICE

This is right unilateral ultrabrief ECT, the standard of care.

RUL UB

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Major Depressive Episode
• Pretreatment Hamilton Depression Score \>21
• ECT indicated
• Willing and able to give informed consent

You may not qualify if:

• History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder
• History of central nervous system illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
• Alcohol or substance abuse or dependence in the past year (DSM-V)
• Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-V), pregnancy, or epilepsy
• Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc.
• No anticonvulsant mood stabilizers (e.g., Depakote, Tegretol, Lamictal); No lithium; No psychostimulants (e.g., Ritalin, Adderall);
• Allowed medications during FEAST/ECT:
• Antidepressants, including buproprion Atypical antipsychotics; Hypnotics for sleep; Anxiolytics (limited to up to 3 mg equivalents/day lorazepam)
• ECT in the past six months

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Augusta University: collaborator

Study Sites (2)

Georgia Regents Medical Center

Augusta, Georgia, 30912, United States

Location

Medical University of South Carolina Brain Stimulation Division

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Nahas Z, Short B, Burns C, Archer M, Schmidt M, Prudic J, Nobler MS, Devanand DP, Fitzsimons L, Lisanby SH, Payne N, Perera T, George MS, Sackeim HA. A feasibility study of a new method for electrically producing seizures in man: focal electrically administered seizure therapy [FEAST]. Brain Stimul. 2013 May;6(3):403-8. doi: 10.1016/j.brs.2013.03.004. Epub 2013 Mar 16.

  PMID: 23518262 BACKGROUND

• Youssef NA, George MS, McCall WV, Sahlem GL, Short B, Kerns S, Manett AJ, Fox JB, Dancy M, Cook D, Devries W, Rosenquist PB, Sackeim HA. The Effects of Focal Electrically Administered Seizure Therapy Compared With Ultrabrief Pulse Right Unilateral Electroconvulsive Therapy on Suicidal Ideation: A 2-Site Clinical Trial. J ECT. 2021 Dec 1;37(4):256-262. doi: 10.1097/YCT.0000000000000776.

  PMID: 34015791 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Morgan Dancy
• Organization: Medical University of South Carolina

maddoxm@musc.edu

843-876-5141

Study Officials

• Mark S George, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: August 1, 2015
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-02

Locations

US (2)