Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The George Institute
With
National Health and Medical Research Council, Australia
Ramsay Clinic Albert Road, Australia
Ramsay Clinic Lakeside, Australia
Ramsay Clinic Northside, Australia
Gold Coast Hospital and Health Service
Augusta University
Medical University of South Carolina
The University of New South Wales
Emory University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 benzodiazepine dosage, as determined by patient's own treating psychiatrist.
ECT indicated for treatment of depression, as determined by own treating referring psychiatrist 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 neuropsychological testing (e.g., worked or studied in an English-speaking context or equivalent)
You may not be if
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 mixed features (DSM-5 diagnoses\*)
Alcohol or substance use disorder (other than caffeine or nicotine) present in the past month, or is likely to be present during the 24-week study period as determined by study physician evaluation
Diagnosis of amnestic disorder, dementia, delirium, or epilepsy, as determined by study physician evaluation and medical history
Central nervous system disease or brain injury that has resulted in significant cognitive impact, as determined by study physician evaluation and medical history
Serious or unstable medical condition, as determined by study physician evaluation and medical history
If female of childbearing potential: a) pregnancy as determined by pregnancy urine screen
Completed an acute course of ECT during the past 2 months, as determined by treatment history
Received any ECT during the past 2 weeks
Failed an adequate course of ECT (i.e., 8 ECT treatments ) in the current depressive episode
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 Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) Version 7.0.2 for DSM-5, administered by research team members.
