Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Device: MECTA Spectrum 5000Q

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • DukeUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500 mA ECT; Right unilateral, ultra brief pulse ECT, with 500 mA current amplitude	Device: MECTA Spectrum 5000Q
Active Comparator: 800 mA ECT; Right unilateral, ultra brief pulse ECT, with 800 mA current amplitude	Device: MECTA Spectrum 5000Q

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in California Verbal Learning Test-II	Baseline and within 24 to 48 hours of each ECT session

Other Outcome Measures

Outcome Measure	Time Frame
Change in Hamilton Rating Scale for Depression 24-item	Baseline and within 24 to 48 hours of each ECT session
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 Delis Kaplan Executive Function System	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Pro00058639