Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Not Applicable

Terminated

• Conditions: Depression
• Interventions: Device: MECTA Spectrum 5000Q

• Registration Number: NCT02351843
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-30
• Study Start: 2015-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-08
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
800 mA ECT	MECTA Spectrum 5000Q	Right unilateral, ultra brief pulse ECT, with 800 mA current amplitude
500 mA ECT	MECTA Spectrum 5000Q	Right unilateral, ultra brief pulse ECT, with 500 mA current amplitude

Primary Outcome Measures

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

Trial Locations

Locations (1)

DukeUMC; 🇺🇸 Durham, North Carolina, United States