Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Stopped early · Not applicable

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT02351843

Run by

Duke University

People needed

1

Starts

2015-02-01

Expected to finish

2015-11-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects, age 18-70
• DSM-IV-TR diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the MINI-PLUS
• MMSE total score > 26
• Referred for ECT
• Competent to provide informed consent
• Able to read or comprehend English

You may not qualify if…

• Lifetime history of schizophrenia, schizoaffective disorder, mental retardation
• Current neurostimulation treatment (e.g., ECT, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation)
• Current alcohol abuse or dependence within past 6 months
• Current substance abuse or dependence within past 6 months
• History of central nervous system (CNS) disease
• Current diagnosis of dementia or delirium
• MoCA total score < 26
• Current visual, auditory, or motor impairment that compromises ability to complete evaluations
• Patients with intracranial implants
• MRI contraindications: pregnancy, implanted metal, and claustrophobia

Where it is running

• DukeUMC — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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