Low Pulse Amplitude Focal ECT (LAP Study)

NCT02583490 | Completed Phase 3 DMC

• 1 other identifier: Low Pulse Amplitude Focal ECT
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Memory (cognitive side effects)

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

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

• Time to reorientation

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

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

Secondary Outcomes (5)

• Resilience

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

• Suicidal Ideation

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

• Depression

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

• Depression

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

• Trauma symptoms

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

Study Arms (2)

Low Pulse Amplitude ECT (LAP)

EXPERIMENTAL

Right Unilateral LAP ECT

Device: spectrum 5000Q ECT device (RUL LAP ECT)

standard Right Unilateral ECT

ACTIVE COMPARATOR

standard Right Unilateral ECT

Device: spectrum 5000Q ECT device (RUL ECT)

Interventions

spectrum 5000Q ECT device (RUL ECT) DEVICE

standard Right Unilateral ECT

spectrum 5000Q ECT device (RUL LAP ECT) DEVICE

Low Pulse Amplitude ECT (LAP)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Medical Colleage of Georgia, Augusta University

Evans, Georgia, 30809, United States

Location

Related Publications (2)

• 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.

  PMID: 31035665 RESULT

• 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.

  PMID: 33215889 DERIVED

MeSH Terms

Conditions

Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Study Officials

• Nagy Youssef, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Psychiatry and Health Behavior

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 22, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

US (1)