DepressionPhase 2/3FEASTNCT02535572
Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment
A Phase 2/3 study testing FEAST and RUL UB in people with Depression, run by Medical University of South Carolina at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Depression
- What is being tested?
- FEAST and RUL UB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to 10 Jun 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Episode
- Pretreatment Hamilton Depression Score >21
- ECT indicated
- Willing and able to give informed consent
Who cannot join
- 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);
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgia Regents Medical Center
Augusta, Georgia, 30912
Medical University of South Carolina Brain Stimulation Division
Charleston, South Carolina, 29425
About this study
Official title: 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 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.
Read more
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.
Read the detailed description
This study will provide preliminary evaluation of the following:
- Further characterization of the efficacy of FEAST and the safety of the treatment.
- The primary efficacy measure will be the 24-item Hamilton Rating Scale for Depression. The changes in these scores from before to immediately following the treatment course (typically after 4 weeks) will be compared in patients treated with the FEAST methodology and matched to nonrandomized patients at our facilities who were treated with conventional ECT methods (ultrabrief right unilateral [RUL] ECT).
- 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 primary subacute measures will be assessment of retrograde amnesia for autobiographical information. 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).
- Safety will also be determined by examining the number and frequency of serious adverse advents and adverse events.
- Characterization of the focal nature of the seizure onset with FEAST and RUL ECT. We will use two main methods to address the issue of focality.
- Resting state fMRI before and after a course of FEAST (or conventional RUL ECT). We will address whether FEAST causes changes in hyper connected prefrontal cortical subcortical networks, and whether such an effect is more restricted to prefrontal cortex with FEAST relative to conventional RUL ECT.
- Peri-ictal EEG acquired immediately before, during and immediately after the FEAST seizure. We will acquire this in all patients at all treatment sessions. Again, for comparison, we will use identical EEG acquisition methods in patients treated with conventional RUL ECT.
- Conditions
- Depression
- Being tested
- FEAST, RUL UB
- Keywords
- Electroconvulsive Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEASTDevice
FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.
RUL UBDevice
This is right unilateral ultrabrief ECT, the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| FEAST | Experimental | Patients will receive the FEAST form of ECT Receives: Device: FEAST |
| RUL UB | Active comparator | Patients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) Receives: Device: RUL UB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 4 weeks
Secondary outcomes (1)
Number of Adverse Events
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.
Measured: From the start of the study through the six month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University
- Responsible party
- Sponsor
- Investigators
- Mark S George, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535572
- Sponsor's protocol ID
- Pro00042678
- Acronym
- FEAST
- Status last verified
- Feb 2021
- First submitted
- 25 Aug 2015
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 23518262Youssef 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.
PubMed 34015791
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Electrically-Administered Seizure Therapy (FEAST): Studies at Two Enrolling Sites to Further Test and Refine the Treatment
- ClinicalTrials.gov ID
- NCT02535572
- Acronym / sponsor ID
- FEAST / Pro00042678
- Conditions
- Depression
- Keywords
- Electroconvulsive Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Augusta University
- Study start
- Aug 2015
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will provide preliminary evaluation of the following:
- Further characterization of the efficacy of FEAST and the safety of the treatment.
- The primary efficacy measure will be the 24-item Hamilton Rating Scale for Depression. The changes in these scores from before to immediately following the treatment course (typically after 4 weeks) will be compared in patients treated with the FEAST methodology and matched to nonrandomized patients at our facilities who were treated with conventional ECT methods (ultrabrief right unilateral [RUL] ECT).
- 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 primary subacute measures will be assessment of retrograde amnesia for autobiographical information. 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).
- Safety will also be determined by examining the number and frequency of serious adverse advents and adverse events.
- Characterization of the focal nature of the seizure onset with FEAST and RUL ECT. We will use two main methods to address the issue of focality.
- Resting state fMRI before and after a course of FEAST (or conventional RUL ECT). We will address whether FEAST causes changes in hyper connected prefrontal cortical subcortical networks, and whether such an effect is more restricted to prefrontal cortex with FEAST relative to conventional RUL ECT.
- Peri-ictal EEG acquired immediately before, during and immediately after the FEAST seizure. We will acquire this in all patients at all treatment sessions. Again, for comparison, we will use identical EEG acquisition methods in patients treated with conventional RUL ECT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEAST | Experimental | Device: FEASTPatients will receive the FEAST form of ECT |
| RUL UB | Active comparator | Device: RUL UBPatients will receive the standard of care, right unilateral ultrabrief ECT (RUL UB) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Major Depressive Episode
- Pretreatment Hamilton Depression Score >21
- ECT indicated
- Willing and able to give informed consent
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEASTFEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes. | Device | FEAST |
| RUL UBThis is right unilateral ultrabrief ECT, the standard of care. | Device | RUL UB |
Primary outcome
Percentage Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression
Time frame: From Baseline to end of acute course (typically after 4 weeks)
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).
Time to Return to Orientation
Time frame: 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).
Retrograde Amnesia for Autobiographical Information Using CUAMI-SF Consistency Scores
Time frame: 4 weeks
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.
1 secondary outcome
Number of Adverse Events
Time frame: From the start of the study through the six month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23518262Nahas 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.
- Derived from this study: PubMed 34015791Youssef 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S George, MD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FEAST and RUL UB in people with Depression, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression (time frame: From Baseline to end of acute course (typically after 4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.