Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment

Completed · Phase 2/Phase 3

Conditions studied: Depression

In brief

This open label investigation further evaluates the safety, efficacy and potential mechanisms of action of a new form of electroconvulsive therapy (ECT). The investigators have recently completed preliminary open-label studies with FEAST, first at Columbia University, and then at the Medical University of South Carolina in Charleston (Nahas et al., 2013b). The investigators have published the outcomes of the first 17 patients studied. One patient withdrew from the study after a single titration session. After the course of FEAST (median 10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale for Depression (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P \< 0.0001). Eight of 16 patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission criteria (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 + 6.4 min (median time = 3.6 min), timed from when their eyes first opened after treatment. The investigators have now studied 18 more patients (see results below), and we are completing the study in the original IDE with another two more patients still to enroll. This work allowed us to refine the treatment. For example, the investigators selectively modified the electrode geometry to decrease interelectrode resistance. Additionally the investigators modified the titration schedule, now only administering a standard 800 ma ultrabrief pulse, and thus no longer titrating in the current domain. In this next proposed trial we will continue to gather efficacy and safety data, and compare these to a parallel non-randomized group receiving ECT standard of care. ECT is typically delivered in a dynamically adaptive manner, with each person having a different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus have to use imprecise time points such as 'at the end of the acute treatment course' rather than specified dates or visits.

Key facts

Study ID: NCT02535572
Run by: Medical University of South Carolina
People needed: 48
Starts: 2015-08-01
Expected to finish: 2019-06-10
Last updated by the study team: 2021-02-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of Major Depressive Episode
Pretreatment Hamilton Depression Score >21
ECT indicated
Willing and able to give informed consent

You may not qualify if…

History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder
History of central nervous system illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
Alcohol or substance abuse or dependence in the past year (DSM-V)
Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-V), pregnancy, or epilepsy
Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc.
No anticonvulsant mood stabilizers (e.g., Depakote, Tegretol, Lamictal); No lithium; No psychostimulants (e.g., Ritalin, Adderall);
Allowed medications during FEAST/ECT:
Antidepressants, including buproprion Atypical antipsychotics; Hypnotics for sleep; Anxiolytics (limited to up to 3 mg equivalents/day lorazepam)
ECT in the past six months

Where it is running

Georgia Regents Medical Center — Augusta, Georgia, United States
Medical University of South Carolina Brain Stimulation Division — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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