Major Depressive DisorderPhase 2/3FEASTNCT01589315
Focal Electroconvulsive Therapy for Depression
A Phase 2/3 study testing focal ECT in people with Major Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This pilot, open label investigation evaluates the safety and efficacy of a new form of electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are highly contingent on the intracerebral current paths and current density of the ECT stimulus. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- focal ECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2016
- 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
- Age between 18 and 90 years (inclusive)
- Diagnosis of major depressive disorder
- Pretreatment HRSD score ≥ 18
- ECT indicated
- Willing and capable of providing informed consent
Who cannot join
- History of schizophrenia,
- schizoaffective disorder,
- other functional psychosis, or
- rapid cycling bipolar disorder
- History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
- Alcohol or substance abuse or dependence in the past year (RDC)
Show all 10Show fewer
- Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy
- Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc.
- Unable to tolerate psychotropic washout and no psychotropic medication during the ECT trial, other than lorazepam (up to 3 mg/d PRN)
- ECT in the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Focal Electrical Administered Seizure Therapy (FEAST) for Major Depression
This pilot, open label investigation evaluates the safety and efficacy of a new form of electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are highly contingent on the intracerebral current paths and current density of the ECT stimulus. However, the impedance of the skull and individual differences in skull anatomy severely limit the spatial targeting of stimulation, and create marked individual differences in intracerebral current density. To address these problems, the investigators are exploring various means of overcoming this limitation.
An approach is to modify the electrical stimulus to induce focal seizures. The most common methods of ECT administration in the US use a bidirectional, constant current, brief pulse, with large (approximately 3 sq. in. surface area) and identically sized and shaped electrodes. In contrast, in this protocol the investigators have coupled unidirectional current flow with an electrode geometry involving a small and large electrode that differ by more than 3:1 in surface area.
Read more
Unidirectional currents were widely used in ECT during the, 1940's and continue to be used in European and American devices today. Transcranial electrical stimulation can be made focal by stimulating with an anode-cathode arrangement, with the electrodes differing in surface area. The investigators have shown in nonhuman primates the capacity to produce focal frontal seizure induction under conditions when a unidirectional current flows from a small anterior anode (placed on the forehead over the nasion) to a large posterior cathode just anterior to the motor strip. Furthermore, the investigators expect that some, if not all, of these seizures do not result in motor convulsions.
Thirty outpatients referred for ECT will participate. Relative to concurrent reference data from our ongoing ECT protocols, the investigators hypothesize that acute and subacute adverse cognitive effects of FEAST will be substantially less than those in patients receiving state-of-the art ECT, but with a traditional bidirectional, nonfocal stimulus. The investigators also hypothesize that the majority of patients will remit with FEAST. Thus, by improving the efficiency of the ECT stimulus with the switch to unidirectional current and the use of a new electrode geometry, the investigators expect to be able to induce focal seizures. The investigators hypothesize that this pilot study will provide evidence that this treatment is superior to traditional ECT in having lower dosing requirements and a superior side effect profile.
Read the detailed description
This study will provide preliminary evaluation of the following:
- Determination of whether focal seizures can be induced with the FEAST methodology (unidirectional stimulation, small anterior and large posterior electrode).
- Focality will be assessed by the occurrence of non-motor seizures.
- Electroencephalographic evidence of pronounced asymmetry in frontal leads.
- Determination of whether the FEAST methodology results in reduced seizure threshold.
- Seizure threshold will be quantified at the start of the treatment course using the standard method of limits titration procedure and compared to threshold determinations in matched patients who were treated with conventional ECT methods.
- Characterization of dynamic impedance using the FEAST methodology.
- Dynamic impedance during the passage of the electrical stimulus will be quantified during each administration and compared to the values obtained in matched patients who were treated with conventional ECT methods.
- Characterization of the efficacy of the FEAST methods 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 will be compared in patients treated with the FEAST methodology and matched patients who were treated with conventional ECT methods.
- Acute, subacute, and long-term cognitive side effects following FEAST will be assessed with comprehensive neuropsychological batteries. The primary acute measures will include the time to return of orientation following seizure induction and retrograde amnesia for words and shapes. The primary subacute measures will include assessments of anterograde amnesia (forgetting over a delay) for a verbal list and for reproduction of a complex figure, as well as retrograde amnesia for autobiographical information. The primary long-term measure will be retrograde amnesia for autobiographical information, assessed 6-months following the FEAST course. The neuropsychological measures will be compared in the patients treated with the FEAST methodology and matched patients who were treated with conventional ECT methods, as well as in healthy participants who receive were administered the neuropsychological battery at the same intervals as the FEAST patients, but without Intervention.
- Safety will also be determined by examining the number and frequency of serious adverse advents and adverse events, as well as scores on the Columbia University ECT Side Effect Scale.
- Conditions
- Major Depressive Disorder
- Being tested
- focal ECT
- Keywords
- ECT, FEAST, brain stimulation, depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focal ECTDevice
Also called FEAST, ultra-brief unidirectional right ECT
FEAST, ECT, unidirectional stimulation
| Study group | Role | What they receive |
|---|---|---|
| FEAST | Experimental | Active right unilateral focal ECT Receives: Device: focal ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission Based on HDRS, Hamilton Depression Rating Scale, 24 Item.
The number of treatment sessions is not fixed and could extend up to 12 provided that patients show continued improvement and tolerate the treatment. With 3 FEAST sessions per week, the course may take up to 12 weeks to be completed.
The Hamilton Rating Scale for Depression is a widely used clinician administered rating.Scores range from (Min) 0 to (Max) 52. Higher score means worse depression. The definition of remission was a Ham Depression Score (24 item) of < or equal to 10.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startJan 2007
- Primary completionAug 2015
- Study completionAug 2016
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 (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziad Nahas, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589315
- Sponsor's protocol ID
- FEAST for depression
- Acronym
- FEAST
- Status last verified
- Aug 2019
- First submitted
- 25 Apr 2012
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sackeim HA. Memory and ECT: from polarization to reconciliation. J ECT. 2000 Jun;16(2):87-96. doi: 10.1097/00124509-200006000-00001. No abstract available.
PubMed 10868319HOVORKA EJ, SCHUMSKY DA, WORK MS. Electroconvulsive thresholds as related to stimulus parameters of unidirectional ECS. J Comp Physiol Psychol. 1960 Aug;53:412-4. doi: 10.1037/h0041786. No abstract available.
PubMed 14403427Nahas 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 23518262
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Electrical Administered Seizure Therapy (FEAST) for Major Depression
- ClinicalTrials.gov ID
- NCT01589315
- Acronym / sponsor ID
- FEAST / FEAST for depression
- Conditions
- Major Depressive Disorder
- Keywords
- ECT, FEAST, brain stimulation, depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot, open label investigation evaluates the safety and efficacy of a new form of electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are highly contingent on the intracerebral current paths and current density of the ECT stimulus. However, the impedance of the skull and individual differences in skull anatomy severely limit the spatial targeting of stimulation, and create marked individual differences in intracerebral current density. To address these problems, the investigators are exploring various means of overcoming this limitation.
An approach is to modify the electrical stimulus to induce focal seizures. The most common methods of ECT administration in the US use a bidirectional, constant current, brief pulse, with large (approximately 3 sq. in. surface area) and identically sized and shaped electrodes. In contrast, in this protocol the investigators have coupled unidirectional current flow with an electrode geometry involving a small and large electrode that differ by more than 3:1 in surface area.
Unidirectional currents were widely used in ECT during the, 1940's and continue to be used in European and American devices today. Transcranial electrical stimulation can be made focal by stimulating with an anode-cathode arrangement, with the electrodes differing in surface area. The investigators have shown in nonhuman primates the capacity to produce focal frontal seizure induction under conditions when a unidirectional current flows from a small anterior anode (placed on the forehead over the nasion) to a large posterior cathode just anterior to the motor strip. Furthermore, the investigators expect that some, if not all, of these seizures do not result in motor convulsions.
Thirty outpatients referred for ECT will participate. Relative to concurrent reference data from our ongoing ECT protocols, the investigators hypothesize that acute and subacute adverse cognitive effects of FEAST will be substantially less than those in patients receiving state-of-the art ECT, but with a traditional bidirectional, nonfocal stimulus. The investigators also hypothesize that the majority of patients will remit with FEAST. Thus, by improving the efficiency of the ECT stimulus with the switch to unidirectional current and the use of a new electrode geometry, the investigators expect to be able to induce focal seizures. The investigators hypothesize that this pilot study will provide evidence that this treatment is superior to traditional ECT in having lower dosing requirements and a superior side effect profile.
Detailed description
This study will provide preliminary evaluation of the following:
- Determination of whether focal seizures can be induced with the FEAST methodology (unidirectional stimulation, small anterior and large posterior electrode).
- Focality will be assessed by the occurrence of non-motor seizures.
- Electroencephalographic evidence of pronounced asymmetry in frontal leads.
- Determination of whether the FEAST methodology results in reduced seizure threshold.
- Seizure threshold will be quantified at the start of the treatment course using the standard method of limits titration procedure and compared to threshold determinations in matched patients who were treated with conventional ECT methods.
- Characterization of dynamic impedance using the FEAST methodology.
- Dynamic impedance during the passage of the electrical stimulus will be quantified during each administration and compared to the values obtained in matched patients who were treated with conventional ECT methods.
- Characterization of the efficacy of the FEAST methods 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 will be compared in patients treated with the FEAST methodology and matched patients who were treated with conventional ECT methods.
- Acute, subacute, and long-term cognitive side effects following FEAST will be assessed with comprehensive neuropsychological batteries. The primary acute measures will include the time to return of orientation following seizure induction and retrograde amnesia for words and shapes. The primary subacute measures will include assessments of anterograde amnesia (forgetting over a delay) for a verbal list and for reproduction of a complex figure, as well as retrograde amnesia for autobiographical information. The primary long-term measure will be retrograde amnesia for autobiographical information, assessed 6-months following the FEAST course. The neuropsychological measures will be compared in the patients treated with the FEAST methodology and matched patients who were treated with conventional ECT methods, as well as in healthy participants who receive were administered the neuropsychological battery at the same intervals as the FEAST patients, but without Intervention.
- Safety will also be determined by examining the number and frequency of serious adverse advents and adverse events, as well as scores on the Columbia University ECT Side Effect Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEAST | Experimental | Device: focal ECTActive right unilateral focal ECT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 90 years (inclusive)
- Diagnosis of major depressive disorder
- Pretreatment HRSD score ≥ 18
- ECT indicated
- Willing and capable of providing informed consent
Key exclusion criteria (10 listed)
- History of schizophrenia,
- schizoaffective disorder,
- other functional psychosis, or
- rapid cycling bipolar disorder
- History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
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 |
|---|---|---|
| focal ECTAlso: FEAST, ultra-brief unidirectional right ECTFEAST, ECT, unidirectional stimulation | Device | FEAST |
Primary outcome
Remission Based on HDRS, Hamilton Depression Rating Scale, 24 Item.
Time frame: up to 4 weeks
The number of treatment sessions is not fixed and could extend up to 12 provided that patients show continued improvement and tolerate the treatment. With 3 FEAST sessions per week, the course may take up to 12 weeks to be completed. The Hamilton Rating Scale for Depression is a widely used clinician administered rating.Scores range from (Min) 0 to (Max) 52. Higher score means worse depression. The definition of remission was a Ham Depression Score (24 item) of < or equal to 10.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10868319Sackeim HA. Memory and ECT: from polarization to reconciliation. J ECT. 2000 Jun;16(2):87-96. doi: 10.1097/00124509-200006000-00001. No abstract available.
- Background: PubMed 14403427HOVORKA EJ, SCHUMSKY DA, WORK MS. Electroconvulsive thresholds as related to stimulus parameters of unidirectional ECS. J Comp Physiol Psychol. 1960 Aug;53:412-4. doi: 10.1037/h0041786. No abstract available.
- Derived from this study: 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.
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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.
Ziad Nahas, MD principal investigator
Medical University of South Carolina
1 site 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 focal ECT in people with Major Depressive Disorder, run by Medical University of South Carolina at 1 site 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 5 inclusion and 10 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 20 Aug 2019). 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?
Remission Based on HDRS, Hamilton Depression Rating Scale, 24 Item. (time frame: up to 4 weeks). 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 NCT01589315, which also lists 3 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 20 Aug 2019.