Clinical trial NCT02583490: Low Pulse Amplitude Focal ECT (LAP Study)
Official title: Low Pulse Amplitude Focal Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Electroconvulsive Therapy
Low Pulse Amplitude Focal Electroconvulsive Therapy
ECT
Depression
Suicidal Ideation
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Memory (cognitive side effects)
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
measure: Time to reorientation
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
Secondary outcomes:
measure: Resilience
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
measure: Suicidal Ideation
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
measure: Depression
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
measure: Depression
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
measure: Trauma symptoms
timeFrame: From Baseline to end of acute course (typically after 4 weeks)
Other outcomes:
Locations:
city: Evans
country: United States
facility: Medical Colleage of Georgia, Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Nagy Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.