Low Pulse Amplitude Focal ECT (LAP Study)

Augusta University11 enrolled

Overview

This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality. The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.

Lower amplitude ECT (LAP) has been shown to induce seizures of adequate duration in a single titration session. This current study is hypothesized to increase stimulation focality, thus hypothetically minimizing cognitive side effects. The central hypothesis is that LAP has significantly less cognitive adverse effects compared to conventional Right Unilateral (RUL) ECT. The study will enroll 10 patients recruited from Medical College of Georgia. Patients referred to ECT service in the Medical College of Georgia usually occurs from clinical services and private physicians and the study will recruit patients who are clinically indicated to do ECT. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Depression

Interventions

spectrum 5000Q ECT device (RUL ECT)DEVICE

spectrum 5000Q ECT device (RUL LAP ECT)DEVICE

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients in whom ECT therapy is clinically indicated * Males or females patients over 20 years of age * Current DSM-IV criteria for major depressive episode * Montgomery-Asberg depression rating scale (MADRS) greater than or equal to 20 * Use of effective method of birth control for women of child-bearing capacity * Patient is medically stable * No anticipated need to alter psychotropic medications for the duration of the study * Ability of patient to fully participate in the informed consent process Exclusion Criteria: * Unstable or serious medical condition that substantially increases risks of ECT or of cognitive impairment * Substance use disorders within 1 week of randomization * History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion that is deemed to affect cognition or safe ECT treatment * Vagal Nerve Stimulator implanted * Female patients who are pregnant or plan to be pregnant during the study breast-feeding * Implanted devices that make ECT unsafe, or a skull defect * Significant cognitive impairment (Mini-Mental State Examination (MMSE) less than 24) * ECT in the past 1 months * Benzodiazepine use will be limited to no more than 3 mg per day of lorazepam or its equivalents. Antidepressants and antipsychotics will be held constant during the ECT course of the study

Locations (1)

Medical Colleage of Georgia, Augusta University

Evans, Georgia, United States