Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

Pro00058639


NCT ID:

NCT02351843


Secondary ID:


Study Acronym:


Brief Title:

Efficacy and Safety of Low Amplitude Electroconvulsive Therapy


Official Title:

Efficacy and Safety of Low Amplitude Electroconvulsive Therapy


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1


Enrollment Type:

Actual


Study Dates

Start Date:February 2015
Completion Date:November 2015
Completion Type:Actual
Primary Completion Date:November 2015
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:March 21, 2017
First Received Date:January 27, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in California Verbal Learning Test-II
Time Frame:Baseline and within 24 to 48 hours of each ECT session
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:MECTA Spectrum 5000Q
Arm Name:500 mA ECT

Study Arms

Study Arm Type:Active Comparator
Arm Name:800 mA ECT
Description:Right unilateral, ultra brief pulse ECT, with 800 mA current amplitude
Study Arm Type:Experimental
Arm Name:500 mA ECT
Description:Right unilateral, ultra brief pulse ECT, with 500 mA current amplitude

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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