Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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500 mA ECT

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

Group Type EXPERIMENTAL

MECTA Spectrum 5000Q

Intervention Type DEVICE

800 mA ECT

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

Group Type ACTIVE_COMPARATOR

MECTA Spectrum 5000Q

Intervention Type DEVICE

Interventions

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MECTA Spectrum 5000Q

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No