Clinical Research Details

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Descriptive Information
Focal Electrically Administered Seizure Therapy (FEAST)

Ziad Nahas
zn17@aub.edu.lb

PSY.ZN.03
Ongoing

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 2  

No
Coordinators
Mark Doumit
md55@aub.edu.lb
Extension: 5666
Conditions and Keywords
Depression,Treatment-resistant Depression
FEAST,Focal Electrically Administered Seizure Therapy,Electro-convulsive Therapy
Study Design
Treatment
Safety and/or Efficacy Study
Open Label
Single Group
N/A: Single arm study
Cohort
Eligibility and IRB
Both
Min: 19
Max: 80
Yes
No

This study investigates the use of a focal administration of the right unilateral configuration of electro-convulsive therapy (ECT) for the treatment of recurrent and treatment-resistant depression. This method is named Focal Electrically Administered Seizure Therapy (FEAST); it was developed to deliver a more focal stimulus to the right hemisphere with a unidirectional current (as opposed to other configurations with a bidirectional current). The frontal electrode (placed a few millimeters above the eyebrow on the forehead) is a smaller size than the classic ECT electrodes while the posterior electrode is larger. This configuration and unidirectional current delivered to the right hemisphere allows the current to be spatially directed to the prefrontal cortex, and reduces the involvement of temporal lobe regions. Preliminary results suggest that with FEAST we may be able to preserve the efficacy of ECT while reducing or eliminating the amnestic side effects.

Patients who fit the inclusion criteria and are referred to ECT will be given information on this study and its aims. After consent is obtained, they will undergo a titration session to measure there seizure threshold after which they will proceed with the treatment course (at 6 times seizure threshold) until the 4th treatment session at which an assessment of symptom severity informs us whether to continue or stop treatment, increase the parameters (to 9 times seizure threshold), or switch to classic ECT configurations.


Patients referred to ECT at the American University of Beirut Medical Center Psychiatry Department for treatment-resistant depression.

Patients referred to ECT at the American University of Beirut Medical Center Psychiatry Department for treatment-resistant depression would be referred to the research team for recruitment and consent. The research assistants and/or fellows would proceed to explain ECT treatment in detail and how this protocol differs from classic ECT and what it would entail to participate. 

  • 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]
  • 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]
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