Treatment-Resistant DepressionFEASTNCT02462551
Focal Electrically Administered Seizure Therapy for the Treatment of Depression
A study testing Focal Electrically Administered Seizure Therapy in people with Treatment-Resistant Depression, run by Ziad Nahas at 1 site in Lebanon.
Trial summary
The purpose of this study is to determine the efficacy and any possible side effects of focal electrically administered seizure therapy (FEAST) as a treatment intervention for patients with recurrent and treatment resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Treatment-Resistant Depression
- What is being tested?
- Focal Electrically Administered Seizure Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (unipolar or bipolar) [SCID to derive RDC; DSM-IV]
- Pretreatment HRSD score ≥ 18 [Hamilton Rating Scale for Depression (24-item)]
- ECT indicated [Physician evaluation]
- Willing and capable of providing informed consent [Physician evaluation]
Who cannot join
- History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder [SADS to derive RDC; rapid cycling defined as ≥ four episodes in past year]
- History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) [Physician evaluation; medical history]
- Alcohol or substance abuse or dependence in the past year (RDC) [Physician evaluation]
- Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy [Physician evaluation]
- Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. [Physician evaluation]
- Unable to tolerate psychotropic washout and no psychotropic medication during the ECT trial, other than lorazepam (up to 3 mg/d PRN) [Treatment history and physician evaluation]
- ECT in the past six months [Physician evaluation; medical history]
- Has a cardiovascular and/or pulmonary condition [Physician evaluation]
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut, Beirut
Ziad Nahas, MD, MSCR, 00961-1-350000 ext. 5664, zn07@aub.edu.lb
Mark Doumit, BA, MA, 00961-1-350000 ext. 5666, md55@aub.edu.lb
About this study
Official title: Investigating the Effects of Focal Electrically Administered Seizure Therapy (FEAST) for the Treatment of Depression
The purpose of this study is to determine the efficacy and any possible side effects of focal electrically administered seizure therapy (FEAST) as a treatment intervention for patients with recurrent and treatment resistant depression.
Read the detailed description
Recurrent and treatment resistant depression (TRD) has high morbidity and escalating costs for the healthcare system and society at large. Electroconvulsive therapy (ECT) remains the most effective acute antidepressant treatment for TRD, but with significant risks of cognitive impairment. The efficacy and side effects of conventional ECT are contingent on the anatomic positioning of electrodes and stimulus dosage. A technique that could spatially target the prefrontal cortex may preserve the efficacy of ECT while simultaneously reducing cognitive side effects.
The investigators have recently demonstrated that focal electrically-administered seizure therapy [FEAST], which markedly improves the spatial targeting of the electrical current, is feasible in adult TRD individuals. FEAST can initiate seizures focally and specifically in the prefrontal cortex prior to secondary seizure generalization. Preliminary results in depressed humans at Columbia University and later at the Medical University of South Carolina (MUSC) generated by the PI (Nahas) show that these focal seizures produce clinically meaningful antidepressant responses. Additional work is needed to refine the technique and compare it to conventional approaches.
In this study, the investigators will further develop FEAST to achieve clinically meaningful remission rates (at least 50% of subjects). 30 TRD patients (or 20 with a complete record) will undergo an open-label course of FEAST for an adaptive number of total sessions designed to maximize efficacy of the technique. The investigators will use a dosing paradigm using a current level of 800 mA, finalize the electrode sizes, and test, at one treatment session, the effects of reversing the directionality of current flow on site of seizure induction. Patients will also undergo electroencephalography (EEG) assessments to characterize the induced seizures' spatial and temporal distributions. The investigators will obtain time to orientation recovery as a marker of potential longer-term cognitive side effects.
This technique could fundamentally change and improve the most effective antidepressant treatment, while simultaneously minimizing or eliminating the major side-effects that prohibit larger adoption of ECT.
- Conditions
- Treatment-Resistant Depression
- Being tested
- Focal Electrically Administered Seizure Therapy
- Keywords
- Depression, Treatment Resistant Depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Electrically Administered Seizure TherapyDevice
Also called FEAST
A focal administration of the right unilateral configuration of electro-convulsive therapy for the treatment of recurrent and treatment-resistant depression.
| Study group | Role | What they receive |
|---|---|---|
| FEAST | Experimental | Patients with treatment-resistant depression will undergo 3 sessions of focal electrically administered seizure therapy for two to six weeks. The complete parameter range of the stimulus delivered (Freq: 20-120 Hz; PW: 0.2-2 ms; Duration: 0.1 to 8 s; Current: 0.5-0.8A; charge: 1-576 mC) is determined by an initial titration session and the PI (as an expert in neuromodulation treatments). Receives: Device: Focal Electrically Administered Seizure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial and temporal distribution and power of induced seizure on EEG recordings
EEG recordings will be analyzed to assess the dynamics and characteristics of induced seizure activity; including spatial and temporal distribution, power, and current density in different cortical areas
Measured: 15 min before to 5 min after stimulus delivery for the first 3 sessions in a maximum period of two weeks
Secondary outcomes (2)
Change in Depression Scores
24-item Hamilton Depression Rating Scale
Measured: Baseline and 4-6 weeks
Time for Reorientation
Five questions are asked after waking up from anesthesia to assess short and long-term memory.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startSep 2013
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Treatment-Resistant DepressionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziad Nahas
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, MECTA corporation, Medical University of South Carolina
- Responsible party
- Sponsor-investigator, Ziad Nahas, American University of Beirut Medical Center
- Investigators
- Ziad Nahas, MD, MSCR, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462551
- Sponsor's protocol ID
- 21024/ PSY.ZN.03
- Acronym
- FEAST
- Status last verified
- Apr 2016
- First submitted
- 2 Jun 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Spellman T, Peterchev AV, Lisanby SH. Focal electrically administered seizure therapy: a novel form of ECT illustrates the roles of current directionality, polarity, and electrode configuration in seizure induction. Neuropsychopharmacology. 2009 Jul;34(8):2002-10. doi: 10.1038/npp.2009.12. Epub 2009 Feb 18.
PubMed 19225453Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.
PubMed 10839336Sackeim HA, Luber B, Moeller JR, Prudic J, Devanand DP, Nobler MS. Electrophysiological correlates of the adverse cognitive effects of electroconvulsive therapy. J ECT. 2000 Jun;16(2):110-20. doi: 10.1097/00124509-200006000-00003.
PubMed 10868321George MS, Nahas Z, Li X, Kozel FA, Anderson B, Yamanaka K, Chae JH, Foust MJ. Novel treatments of mood disorders based on brain circuitry (ECT, MST, TMS, VNS, DBS). Semin Clin Neuropsychiatry. 2002 Oct;7(4):293-304. doi: 10.1053/scnp.2002.35229.
PubMed 12382211Nahas 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 23518262Chahine G, Short B, Spicer K, Schmidt M, Burns C, Atoui M, George MS, Sackeim HA, Nahas Z. Regional cerebral blood flow changes associated with focal electrically administered seizure therapy (FEAST). Brain Stimul. 2014 May-Jun;7(3):483-5. doi: 10.1016/j.brs.2014.02.011. Epub 2014 Feb 22.
PubMed 24795198Nobler MS, Luber B, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. I. Global analyses. J ECT. 2000 Sep;16(3):211-28. doi: 10.1097/00124509-200009000-00002.
PubMed 11005043Luber B, Nobler MS, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. II. Topographic analyses. J ECT. 2000 Sep;16(3):229-43. doi: 10.1097/00124509-200009000-00003.
PubMed 11005044Kayser S, Bewernick BH, Grubert C, Hadrysiewicz BL, Axmacher N, Schlaepfer TE. Antidepressant effects, of magnetic seizure therapy and electroconvulsive therapy, in treatment-resistant depression. J Psychiatr Res. 2011 May;45(5):569-76. doi: 10.1016/j.jpsychires.2010.09.008. Epub 2010 Oct 16.
PubMed 20951997
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Focal Electrically Administered Seizure Therapy (FEAST) for the Treatment of Depression
- ClinicalTrials.gov ID
- NCT02462551
- Acronym / sponsor ID
- FEAST / 21024/ PSY.ZN.03
- Conditions
- Treatment-Resistant Depression
- Keywords
- Depression, Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ziad NahasUniversity, hospital or other
- Collaborators
- Columbia University, MECTA corporation, Medical University of South Carolina
- Study start
- Sep 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and any possible side effects of focal electrically administered seizure therapy (FEAST) as a treatment intervention for patients with recurrent and treatment resistant depression.
Detailed description
Recurrent and treatment resistant depression (TRD) has high morbidity and escalating costs for the healthcare system and society at large. Electroconvulsive therapy (ECT) remains the most effective acute antidepressant treatment for TRD, but with significant risks of cognitive impairment. The efficacy and side effects of conventional ECT are contingent on the anatomic positioning of electrodes and stimulus dosage. A technique that could spatially target the prefrontal cortex may preserve the efficacy of ECT while simultaneously reducing cognitive side effects.
The investigators have recently demonstrated that focal electrically-administered seizure therapy [FEAST], which markedly improves the spatial targeting of the electrical current, is feasible in adult TRD individuals. FEAST can initiate seizures focally and specifically in the prefrontal cortex prior to secondary seizure generalization. Preliminary results in depressed humans at Columbia University and later at the Medical University of South Carolina (MUSC) generated by the PI (Nahas) show that these focal seizures produce clinically meaningful antidepressant responses. Additional work is needed to refine the technique and compare it to conventional approaches.
In this study, the investigators will further develop FEAST to achieve clinically meaningful remission rates (at least 50% of subjects). 30 TRD patients (or 20 with a complete record) will undergo an open-label course of FEAST for an adaptive number of total sessions designed to maximize efficacy of the technique. The investigators will use a dosing paradigm using a current level of 800 mA, finalize the electrode sizes, and test, at one treatment session, the effects of reversing the directionality of current flow on site of seizure induction. Patients will also undergo electroencephalography (EEG) assessments to characterize the induced seizures' spatial and temporal distributions. The investigators will obtain time to orientation recovery as a marker of potential longer-term cognitive side effects.
This technique could fundamentally change and improve the most effective antidepressant treatment, while simultaneously minimizing or eliminating the major side-effects that prohibit larger adoption of ECT.
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 Electrically Administered Seizure TherapyPatients with treatment-resistant depression will undergo 3 sessions of focal electrically administered seizure therapy for two to six weeks. The complete parameter range of the stimulus delivered (Freq: 20-120 Hz; PW: 0.2-2 ms; Duration: 0.1 to 8 s; Current: 0.5-0.8A; charge: 1-576 mC) is determined by an initial titration session and the PI (as an expert in neuromodulation treatments). |
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 (unipolar or bipolar) [SCID to derive RDC; DSM-IV]
- Pretreatment HRSD score ≥ 18 [Hamilton Rating Scale for Depression (24-item)]
- ECT indicated [Physician evaluation]
- Willing and capable of providing informed consent [Physician evaluation]
Key exclusion criteria (8 listed)
- History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder [SADS to derive RDC; rapid cycling defined as ≥ four episodes in past year]
- History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) [Physician evaluation; medical history]
- Alcohol or substance abuse or dependence in the past year (RDC) [Physician evaluation]
- Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy [Physician evaluation]
- Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. [Physician evaluation]
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 Electrically Administered Seizure TherapyAlso: FEASTA focal administration of the right unilateral configuration of electro-convulsive therapy for the treatment of recurrent and treatment-resistant depression. | Device | FEAST |
Primary outcome
Spatial and temporal distribution and power of induced seizure on EEG recordings
Time frame: 15 min before to 5 min after stimulus delivery for the first 3 sessions in a maximum period of two weeks
EEG recordings will be analyzed to assess the dynamics and characteristics of induced seizure activity; including spatial and temporal distribution, power, and current density in different cortical areas
2 secondary outcomes
Change in Depression Scores
Time frame: Baseline and 4-6 weeks
Time for Reorientation
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Background: PubMed 19225453Spellman T, Peterchev AV, Lisanby SH. Focal electrically administered seizure therapy: a novel form of ECT illustrates the roles of current directionality, polarity, and electrode configuration in seizure induction. Neuropsychopharmacology. 2009 Jul;34(8):2002-10. doi: 10.1038/npp.2009.12. Epub 2009 Feb 18.
- Background: PubMed 10839336Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.
- Background: PubMed 10868321Sackeim HA, Luber B, Moeller JR, Prudic J, Devanand DP, Nobler MS. Electrophysiological correlates of the adverse cognitive effects of electroconvulsive therapy. J ECT. 2000 Jun;16(2):110-20. doi: 10.1097/00124509-200006000-00003.
- Background: PubMed 12382211George MS, Nahas Z, Li X, Kozel FA, Anderson B, Yamanaka K, Chae JH, Foust MJ. Novel treatments of mood disorders based on brain circuitry (ECT, MST, TMS, VNS, DBS). Semin Clin Neuropsychiatry. 2002 Oct;7(4):293-304. doi: 10.1053/scnp.2002.35229.
- 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.
- Background: PubMed 24795198Chahine G, Short B, Spicer K, Schmidt M, Burns C, Atoui M, George MS, Sackeim HA, Nahas Z. Regional cerebral blood flow changes associated with focal electrically administered seizure therapy (FEAST). Brain Stimul. 2014 May-Jun;7(3):483-5. doi: 10.1016/j.brs.2014.02.011. Epub 2014 Feb 22.
- Background: PubMed 11005043Nobler MS, Luber B, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. I. Global analyses. J ECT. 2000 Sep;16(3):211-28. doi: 10.1097/00124509-200009000-00002.
- Background: PubMed 11005044Luber B, Nobler MS, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. II. Topographic analyses. J ECT. 2000 Sep;16(3):229-43. doi: 10.1097/00124509-200009000-00003.
- Background: PubMed 20951997Kayser S, Bewernick BH, Grubert C, Hadrysiewicz BL, Axmacher N, Schlaepfer TE. Antidepressant effects, of magnetic seizure therapy and electroconvulsive therapy, in treatment-resistant depression. J Psychiatr Res. 2011 May;45(5):569-76. doi: 10.1016/j.jpsychires.2010.09.008. Epub 2010 Oct 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, MSCR principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Electrically Administered Seizure Therapy in people with Treatment-Resistant Depression, run by Ziad Nahas at 1 site in Lebanon.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. 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 Lebanon. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziad Nahas, MD, MSCR (00961-1-350000 ext. 5664, zn17@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial and temporal distribution and power of induced seizure on EEG recordings (time frame: 15 min before to 5 min after stimulus delivery for the first 3 sessions in a maximum period of two 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 NCT02462551, which also lists 9 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 6 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.