Depression
Conditions
Brief summary
The purpose of this study is to demonstrate the clinical feasibility of low amplitude electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low amplitude ECT could potentially reduce the risks associated with ECT while preserving its unparalleled efficacy. This novel development would remove key obstacles to allow for the wider adoption of ECT as a safe and effective therapy.
Interventions
DEVICEMECTA Spectrum 5000Q
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects, age 18-70 2. DSM-IV-TR diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the MINI-PLUS 3. MMSE total score \> 26 4. Referred for ECT 5. Competent to provide informed consent 6. Able to read or comprehend English
Exclusion criteria
1. Lifetime history of schizophrenia, schizoaffective disorder, mental retardation 2. Current neurostimulation treatment (e.g., ECT, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation) 3. Current alcohol abuse or dependence within past 6 months 4. Current substance abuse or dependence within past 6 months 5. History of central nervous system (CNS) disease 6. Current diagnosis of dementia or delirium 7. MoCA total score \< 26 8. Current visual, auditory, or motor impairment that compromises ability to complete evaluations 9. Patients with intracranial implants 10. MRI contraindications: pregnancy, implanted metal, and claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in California Verbal Learning Test-II | Baseline and within 24 to 48 hours of each ECT session |
Other
| Measure | Time frame |
|---|---|
| Change in Quick Inventory of Depressive Symptomatology Clinician Rated and Self Report | Baseline and within 24 to 48 hours of each ECT session |
| Change in Brief Visuospatial Memory Test-Revised | Baseline and within 24 to 48 hours of each ECT session |
| Change in Autobiographical Memory Interview Test | Baseline and within 24 to 48 hours of each ECT session |
| Change in Hamilton Rating Scale for Depression 24-item | Baseline and within 24 to 48 hours of each ECT session |
| Change in Trail Making Test Part A | Baseline and within 24 to 48 hours of each ECT session |
| Change in Grooved Pegboard test | Baseline and within 24 to 48 hours of each ECT session |
| Change in Delis Kaplan Executive Function System | Baseline and within 24 to 48 hours of each ECT session |
Countries
United States
Outcome results
None listed