Focal Electrically Administered Seizure Therapy for the Treatment of Depression (FEAST)

April 5, 2016 updated by: Ziad Nahas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • American University of Beirut Medical Center
        • Contact:
          • Ziad Nahas, MD, MSCR
          • Phone Number: 5664 00961-1-350000
          • Email: zn07@aub.edu.lb
        • Contact:
          • Mark Doumit, BA, MA
          • Phone Number: 5666 00961-1-350000
          • Email: md55@aub.edu.lb
        • Principal Investigator:
          • Ziad Nahas, MD, MSCR
        • Sub-Investigator:
          • Mark Doumit, BA, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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]

Exclusion Criteria:

  • 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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FEAST
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).
Device: Focal Electrically Administered Seizure Therapy
A focal administration of the right unilateral configuration of electro-convulsive therapy for the treatment of recurrent and treatment-resistant depression.
Other Names:
  • FEAST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 min before to 5 min after stimulus delivery for the first 3 sessions in a maximum period of two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Scores
Time Frame: Baseline and 4-6 weeks
24-item Hamilton Depression Rating Scale
Baseline and 4-6 weeks
Time for Reorientation
Time Frame: 30 minutes
Five questions are asked after waking up from anesthesia to assess short and long-term memory.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziad Nahas

Collaborators

Medical University of South Carolina
Columbia University
MECTA corporation

Investigators

  • Principal Investigator: Ziad Nahas, MD, MSCR, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21024/ PSY.ZN.03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment-Resistant Depression

Clinical Trials on Focal Electrically Administered Seizure Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe