The RAFT ECT Study

Inclusion Criteria:

• DSM-5 diagnosis* of major depressive episode (unipolar or bipolar)

• HRSD-17 score ≥ 17 at Screening

• At least 18 years old

• Able to tolerate washout of prohibited medications and restriction on benzodiazepinedosage, as determined by patient's own treating psychiatrist.

• ECT indicated for treatment of depression, as determined by own treating referringpsychiatrist and confirmed by research evaluations (e.g., diagnosis of depression)

• Willing and able to participate in research and comply with study requirements

• Sufficient proficiency in spoken English to ensure validity of neuropsychologicaltesting (e.g., worked or studied in an English-speaking context or equivalent)

Exclusion Criteria:

• History of schizophrenia, schizoaffective disorder, other [non-mood disorder]psychosis, or rapid cycling bipolar disorder (DSM-5 diagnoses*)

• Current manic episode, hypomanic episode, or major depressive episode with mixedfeatures (DSM-5 diagnoses*)

• Alcohol or substance use disorder (other than caffeine or nicotine) present in thepast month, or is likely to be present during the 24-week study period as determinedby study physician evaluation

• Diagnosis of amnestic disorder, dementia, delirium, or epilepsy, as determined bystudy physician evaluation and medical history

• Central nervous system disease or brain injury that has resulted in significantcognitive impact, as determined by study physician evaluation and medical history

• Serious or unstable medical condition, as determined by study physician evaluationand medical history

• If female of childbearing potential: a) pregnancy as determined by pregnancy urinescreen

• Completed an acute course of ECT during the past 2 months, as determined bytreatment history

• Received any ECT during the past 2 weeks

• Failed an adequate course of ECT (i.e., 8 ECT treatments ) in the current depressiveepisode

• Patients who are prisoners, and those who lack capacity to make medical decisions (as judged by their own treating psychiatrist)

• Currently enrolled in another interventional clinical trial

• Currently using another investigational device or product

• DSM-5 psychiatric diagnoses will be assessed and confirmed using the MiniInternational Neuropsychiatric Interview (MINI; Sheehan et al., 1998) Version 7.0.2 for DSM-5, administered by research team members.