Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Duke University

Status: Terminated

Conditions: Depression

Treatments: Device: MECTA Spectrum 5000Q

Study type: Interventional

Funder types: Other

Identifiers

NCT02351843

Pro00058639

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

500 mA ECT

Experimental group

Description:

Right unilateral, ultra brief pulse ECT, with 500 mA current amplitude

Treatment:

Device: MECTA Spectrum 5000Q

800 mA ECT

Active Comparator group

Description:

Right unilateral, ultra brief pulse ECT, with 800 mA current amplitude

Treatment:

Device: MECTA Spectrum 5000Q