DepressionPhase 3NCT02583490
Low Pulse Amplitude Focal ECT (LAP Study)
A Phase 3 study testing spectrum 5000Q ECT device (RUL ECT) and spectrum 5000Q ECT device (RUL LAP ECT) in people with Depression, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depression
- What is being tested?
- spectrum 5000Q ECT device (RUL ECT) and spectrum 5000Q ECT device (RUL LAP ECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Colleage of Georgia, Augusta University
Evans, Georgia, 30809
About this study
Official title: Low Pulse Amplitude Focal Electroconvulsive Therapy
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.
Read the 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.
- Conditions
- Depression
- Being tested
- spectrum 5000Q ECT device (RUL ECT), spectrum 5000Q ECT device (RUL LAP ECT)
- Keywords
- Electroconvulsive Therapy, Low Pulse Amplitude Focal Electroconvulsive Therapy, ECT, Depression, Suicidal Ideation
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectrum 5000Q ECT device (RUL ECT)Device
spectrum 5000Q ECT device (RUL LAP ECT)Device
| Study group | Role | What they receive |
|---|---|---|
| Low Pulse Amplitude ECT (LAP) | Experimental | Right Unilateral LAP ECT Receives: Device: spectrum 5000Q ECT device (RUL LAP ECT) |
| standard Right Unilateral ECT | Active comparator | standard Right Unilateral ECT Receives: Device: spectrum 5000Q ECT device (RUL ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory (cognitive side effects)
Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)
Measured: From Baseline to end of acute course (typically after 4 weeks)
Time to reorientation
Measured by Time to Orientation Test (TRO, primary outcome)
Measured: From Baseline to end of acute course (typically after 4 weeks)
Secondary outcomes (5)
Resilience
Connor-Davidson Resilience Scale
Measured: From Baseline to end of acute course (typically after 4 weeks)
Suicidal Ideation
Measured: From Baseline to end of acute course (typically after 4 weeks)
Depression
used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: From Baseline to end of acute course (typically after 4 weeks)
Depression
Patient Health Questionnaire (PHQ 9)
Measured: From Baseline to end of acute course (typically after 4 weeks)
Trauma symptoms
PTSD Checklist
Measured: From Baseline to end of acute course (typically after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Adel Youssef, Augusta University
- Investigators
- Nagy Youssef, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583490
- Sponsor's protocol ID
- Low Pulse Amplitude Focal ECT
- Status last verified
- Jun 2019
- First submitted
- 13 Oct 2015
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31035665Youssef 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.
PubMed 33215889
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Pulse Amplitude Focal Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT02583490
- Acronym / sponsor ID
- Low Pulse Amplitude Focal ECT
- Conditions
- Depression
- Keywords
- Electroconvulsive Therapy, Low Pulse Amplitude Focal Electroconvulsive Therapy, ECT, Depression, Suicidal Ideation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pulse Amplitude ECT (LAP) | Experimental | Device: spectrum 5000Q ECT device (RUL LAP ECT)Right Unilateral LAP ECT |
| standard Right Unilateral ECT | Active comparator | Device: spectrum 5000Q ECT device (RUL ECT)standard Right Unilateral ECT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectrum 5000Q ECT device (RUL ECT) | Device | standard Right Unilateral ECT |
| spectrum 5000Q ECT device (RUL LAP ECT) | Device | Low Pulse Amplitude ECT (LAP) |
Primary outcome
Memory (cognitive side effects)
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)
Time to reorientation
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Measured by Time to Orientation Test (TRO, primary outcome)
5 secondary outcomes
Resilience
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Suicidal Ideation
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Depression
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Depression
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Trauma symptoms
Time frame: From Baseline to end of acute course (typically after 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Results publication: PubMed 31035665Youssef 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.
- Derived from this study: PubMed 33215889Youssef 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.
Related trials for Depression
Not yet recruiting
The Lucida Project
Depression Disorder
Recruiting
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Depressive Disorder, Treatment-Resistant, Memory Deficits
RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagy Youssef, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spectrum 5000Q ECT device (RUL ECT) and spectrum 5000Q ECT device (RUL LAP ECT) in people with Depression, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory (cognitive side effects) (time frame: From Baseline to end of acute course (typically after 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583490, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.