Major Depressive Disorder Clinical Trial
— FEASTOfficial title:
Focal Electrical Administered Seizure Therapy (FEAST) for Major Depression
Verified date | August 2019 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
HOVORKA EJ, SCHUMSKY DA, WORK MS. Electroconvulsive thresholds as related to stimulus parameters of unidirectional ECS. J Comp Physiol Psychol. 1960 Aug;53:412-4. — View Citation
Sackeim HA. Memory and ECT: from polarization to reconciliation. J ECT. 2000 Jun;16(2):87-96. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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