Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Depression Clinical Trial

Official title:

Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02351843
• Other study ID #: Pro00058639
• Status: Terminated
• Phase: N/A
• First received: January 27, 2015
• Last updated: March 21, 2017
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• MECTA Spectrum 5000Q

Locations

Country	Name	City	State
United States	DukeUMC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hamilton Rating Scale for Depression 24-item		Baseline and within 24 to 48 hours of each ECT session
Other	Change in Quick Inventory of Depressive Symptomatology Clinician Rated and Self Report		Baseline and within 24 to 48 hours of each ECT session
Other	Change in Brief Visuospatial Memory Test-Revised		Baseline and within 24 to 48 hours of each ECT session
Other	Change in Autobiographical Memory Interview Test		Baseline and within 24 to 48 hours of each ECT session
Other	Change in Delis Kaplan Executive Function System		Baseline and within 24 to 48 hours of each ECT session
Other	Change in Trail Making Test Part A		Baseline and within 24 to 48 hours of each ECT session
Other	Change in Grooved Pegboard test		Baseline and within 24 to 48 hours of each ECT session
Primary	Change in California Verbal Learning Test-II		Baseline and within 24 to 48 hours of each ECT session