Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
Background: Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST.
Objective: To see if iLAST is safe and feasible in treating depression.
Eligibility: People ages 22 70 years old who have major depressive disorder and are eligible for ECT
Design: Participants will be screened under protocol 01-M-0254. This includes: Medical and psychiatric history and exam Blood and urine tests Participants will be inpatients at the Clinical Center. They study has 3 phases and will last up to 20 weeks. Phase I will last 1 week. It includes: MRI: Participants will lie in a scanner that takes pictures of the body MEG: A cone over the participant s head will record brain activity. TMS: A wire coil placed on the participant s scalp will produce an electrical current to affect brain activity. SEP: An electrode on the participant s wrist will give a small electrical shock to test nerve function. Phase II will last 2 and a half weeks. It includes: Seven sessions of iLAST under general anesthesia. Participants may also get standard ECT. EEG: A small electrode placed on the participant s scalp will record brain waves. Interviews about mood, symptoms, and side effects. Participants facial expressions may be video recorded. TMS Phase III will last at least 1 week. It will include: MRI EEG TMS MEG Standard ECT if needed. Participants will have sessions every other day, 3 times a week.
• Male and female, 22-70 years old
• Use of effective method of birth control for women of childbearing capacity. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test at screening.
• DSM-5 diagnosis of major depressive disorder, confirmed by the structured clinical interview for the DSM 5 (SCID)
• Eligible for ECT, including patients receiving maintenance ECT
• Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document
• Subjects are willing and able to adhere to the intensive treatment schedule and all required study procedures
• On a stable dose of all psychotropic medications (no new medications, discontinuations or dose changes) for 4 weeks prior to baseline assessment and agreement not to change psychotropic medications during the experimental phase (Phase II) of the study, unless advised otherwise by the Investigator.