Efficacy and Safety of Low Amplitude Electroconvulsive Therapy



Status:Terminated
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:3/23/2017
Start Date:February 2015
End Date:November 2015

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
DukeUMC
Durham, North Carolina 27710
Phone: 919-681-0934
?
mi
from
Durham, NC
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