Trial Outcomes & Findings for Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment (NCT NCT02535572)

Last Updated: 2021-02-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

48 participants

Primary outcome timeframe

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

Results posted on

2021-02-04

Participant Flow

48 participants were recruited, however only 41 subjects received treatment. 7 subjects withdrew before the treatment began for the following reasons:changed their mind about research (2), time contraints (3), financial reasons (1), no longer met inclusion criteria (1).

Participant milestones

Participant milestones
Measure	FEAST Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB (Right Unilateral Ultrabrief Electroconvulsive Therapy) Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Overall Study STARTED	21	20
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FEAST n=20 Participants Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 Participants Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	45.15 years STANDARD_DEVIATION 12.68 • n=5 Participants	43.16 years STANDARD_DEVIATION 16.44 • n=7 Participants	44.17 years STANDARD_DEVIATION 14.47 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	FEAST n=20 Participants Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 Participants Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Percentage Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression	60.83 percentage of change in score Standard Deviation 18.36	61.81 percentage of change in score Standard Deviation 20.80

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	FEAST n=20 Participants Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 Participants Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Time to Return to Orientation	6.56 minutes Standard Deviation 5.03	8.79 minutes Standard Deviation 5.83

PRIMARY outcome

Timeframe: 4 weeks

Population: intent to treat sample

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.

Outcome measures

Outcome measures
Measure	FEAST n=20 Participants Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 Participants Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Retrograde Amnesia for Autobiographical Information Using CUAMI-SF Consistency Scores	69.64 percentage of consistent responses Standard Deviation 15.08	64.66 percentage of consistent responses Standard Deviation 9.83

SECONDARY outcome

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

Population: Participants that met inclusion criteria and are included in the analysis group

Safety will also be determined by examining the number and frequency of serious adverse advents and adverse events from the start of the study through the six month follow up.

Outcome measures

Outcome measures
Measure	FEAST n=20 Participants Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 Participants Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Number of Adverse Events headache	108 adverse events	99 adverse events
Number of Adverse Events nausea	35 adverse events	50 adverse events
Number of Adverse Events muscle ache	32 adverse events	46 adverse events

Adverse Events

FEAST

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

RUL UB

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FEAST n=20 participants at risk Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 participants at risk Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Psychiatric disorders Suicide Attempt	0.00% 0/20 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	5.3% 1/19 • Number of events 1 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.
Reproductive system and breast disorders Spontaneous Abortion	0.00% 0/20 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	5.3% 1/19 • Number of events 1 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.

Other adverse events

Other adverse events
Measure	FEAST n=20 participants at risk Patients will receive the FEAST form of ECT FEAST: FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.	RUL UB n=19 participants at risk Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) RUL UB: This is right unilateral ultrabrief ECT, the standard of care.
Nervous system disorders prolonged seizure	5.0% 1/20 • Number of events 1 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	0.00% 0/19 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.
Nervous system disorders postictal agitation),	5.0% 1/20 • Number of events 1 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	0.00% 0/19 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.
Nervous system disorders postictal delirium	0.00% 0/20 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	5.3% 1/19 • Number of events 1 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.
Nervous system disorders headache	80.0% 16/20 • Number of events 108 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	89.5% 17/19 • Number of events 99 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.
Gastrointestinal disorders Nausea	35.0% 7/20 • Number of events 35 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	52.6% 10/19 • Number of events 50 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.
Musculoskeletal and connective tissue disorders muscle ache	50.0% 10/20 • Number of events 32 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.	73.7% 14/19 • Number of events 46 • Adverse events have been collected throughout the duration of the study, from the beginning of the treatments through the 6 month follow up.

Additional Information

Morgan Dancy

Medical University of South Carolina

Phone: 843-876-5141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place