Back to results

Low Pulse Amplitude Focal ECT (LAP Study)

Primary Purpose

Depression

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

spectrum 5000Q ECT device (RUL ECT)

spectrum 5000Q ECT device (RUL LAP ECT)

About this trial

This is an interventional treatment trial for Depression focused on measuring Electroconvulsive Therapy, Low Pulse Amplitude Focal Electroconvulsive Therapy, ECT, Depression, Suicidal Ideation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical Colleage of Georgia, Augusta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Pulse Amplitude ECT (LAP)

standard Right Unilateral ECT

Arm Description

Right Unilateral LAP ECT

standard Right Unilateral ECT

Outcomes

Primary Outcome Measures

Memory (cognitive side effects)

Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)

Time to reorientation

Measured by Time to Orientation Test (TRO, primary outcome)

Secondary Outcome Measures

Resilience

Connor-Davidson Resilience Scale

Suicidal Ideation

Depression

used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Depression

Patient Health Questionnaire (PHQ 9)

Trauma symptoms

PTSD Checklist

Full Information

NCT ID

NCT02583490

First Posted

October 13, 2015

Last Updated

June 18, 2019

Sponsor

Augusta University

1. Study Identification

Unique Protocol Identification Number

NCT02583490

Brief Title

Low Pulse Amplitude Focal ECT (LAP Study)

Official Title

Low Pulse Amplitude Focal Electroconvulsive Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Electroconvulsive Therapy, Low Pulse Amplitude Focal Electroconvulsive Therapy, ECT, Depression, Suicidal Ideation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Pulse Amplitude ECT (LAP)

Arm Type

Experimental

Arm Description

Right Unilateral LAP ECT

Arm Title

standard Right Unilateral ECT

Arm Type

Active Comparator

Arm Description

standard Right Unilateral ECT

Intervention Type

Device

Intervention Name(s)

spectrum 5000Q ECT device (RUL ECT)

Intervention Type

Device

Intervention Name(s)

spectrum 5000Q ECT device (RUL LAP ECT)

Primary Outcome Measure Information:

Title

Memory (cognitive side effects)

Description

Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

Title

Time to reorientation

Description

Measured by Time to Orientation Test (TRO, primary outcome)

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

Secondary Outcome Measure Information:

Title

Resilience

Description

Connor-Davidson Resilience Scale

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

Title

Suicidal Ideation

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

Title

Depression

Description

used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

Title

Depression

Description

Patient Health Questionnaire (PHQ 9)

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

Title

Trauma symptoms

Description

PTSD Checklist

Time Frame

From Baseline to end of acute course (typically after 4 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nagy Youssef, MD

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Colleage of Georgia, Augusta University

City

Evans

State/Province

Georgia

ZIP/Postal Code

30809

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31035665

Citation

Youssef NA, Ravilla D, Patel C, Yassa M, Sadek R, Zhang LF, McCloud L, McCall WV, Rosenquist PB. Magnitude of Reduction and Speed of Remission of Suicidality for Low Amplitude Seizure Therapy (LAP-ST) Compared to Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial. Brain Sci. 2019 Apr 29;9(5):99. doi: 10.3390/brainsci9050099.

Results Reference

result

PubMed Identifier

33215889

Citation

Youssef NA, Dhanani S, Rosenquist PB, McCloud L, McCall WV. Treating Posttraumatic Stress Disorder Symptoms With Low Amplitude Seizure Therapy (LAP-ST) Compared With Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial. J ECT. 2020 Dec;36(4):291-295. doi: 10.1097/YCT.0000000000000701.

Results Reference

derived

Learn more about this trial

Low Pulse Amplitude Focal ECT (LAP Study)

We'll reach out to this number within 24 hrs