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

This study will provide preliminary evaluation of the following:

• Further characterization of the efficacy of FEAST and the safety of the treatment.

• The primary efficacy measure will be the 24-item Hamilton Rating Scale for Depression. The changes in these scores from before to immediately following the treatment course (typically after 4 weeks) will be compared in patients treated with the FEAST methodology and matched to nonrandomized patients at our facilities who were treated with conventional ECT methods (ultrabrief right unilateral [RUL] ECT).
• Acute and subacute cognitive side effects following FEAST will be assessed with a brief neuropsychological battery. The primary acute measures will be the time to return of orientation following seizure induction. The primary subacute measures will be assessment of retrograde amnesia for autobiographical information. The neuropsychological measures will be compared in the patients treated with the FEAST methodology (under this IDE) and matched (but nonrandomized) patients who are treated with conventional ECT methods (also covered under this IDE).
• Safety will also be determined by examining the number and frequency of serious adverse advents and adverse events.
• Characterization of the focal nature of the seizure onset with FEAST and RUL ECT. We will use two main methods to address the issue of focality.

• Resting state fMRI before and after a course of FEAST (or conventional RUL ECT). We will address whether FEAST causes changes in hyper connected prefrontal cortical subcortical networks, and whether such an effect is more restricted to prefrontal cortex with FEAST relative to conventional RUL ECT.
• Peri-ictal EEG acquired immediately before, during and immediately after the FEAST seizure. We will acquire this in all patients at all treatment sessions. Again, for comparison, we will use identical EEG acquisition methods in patients treated with conventional RUL ECT.

Inclusion criteria

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

Exclusion criteria

• 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