Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529029
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAP-ST vs ECT
Brief Summary:
This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation SI at baseline and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy RUL LAP-ST treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy RUL ECT based on our prior secondary analysis Our central hypothesis is that RUL LAP-ST has significantly less cognitivememory side effects no memory side effects were noted in our prior studies for 500mA and 600mA and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT while maintaining better anti-suicidal effect
Detailed Description:
Suicide is one of the leading causes of mortality Suicidal Ideation SI is a precursor to suicide SI is especially hard to treatremit in those with treatment-resistant psychiatric disorders TRPD This includes treatment-resistant mood disorders and psychotic disorders such as schizophrenia and schizoaffective disorders The above TRPD and the SI can remit with Electroconvulsive Therapy ECT That is to say a transdiagnostic evidence-based treatment for those patients in addition to pharmacotherapy and psychotherapy is ECT ECT has both research support mainly secondary analysis and clinical evidence of a beneficial effect in remission of suicidality as well as unsurpassed effect in treating primary mood and psychotic disorders including those who are treatment-resistant to other therapeutics However there are undeniable barriers to treatment with ECT The most important barrier is memory side effects ECT can help SI ECT has also been shown to improve quality of life in a randomized trial by our group which studied elderly patients with depression Treating SI along with the underlying disorder especially in patients with TRPD is crucial in real-world patients who are clinically referred for ECT These real-world referrals to ECT by the patients primary psychiatrist will constitute the recruitment pool for this study
Current amplitude drives electric fields to the deeper structures that are concerned with memory Peterchev et al 2010 Previously the investigators performed the first in human proof of concept one arm open label clinical trial of LAP-ST N22 followed by another small N7 pilot randomized double-blinded clinical trial for the feasibility safely and initial efficacy of LAP-ST and another group later confirmed the more favorable cognitive side effects of LAP-ST compared to higher current amplitude 800mA
However efficacy of LAP-ST against suicidality has not been well established as primary outcome previously
Thus this protocol proposes an initial randomized clinical trial that includes all patients with SI at baseline and with SI as the primary outcome measure to examine whether RUL LAP-ST treatment has more magnitude and rate of remission of SI as conventional pulse amplitude RUL ECT based on our prior secondary analysis Our central hypothesis is that RUL LAP-ST has significantly less cognitivememory side effects no memory side effects were noted in our prior studies for 500mA or 600mA and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT while maintaining better anti-suicidal effect
Current amplitude drives electric fields to the deeper structures that are concerned with memory Peterchev et al 2010 Previously the investigators performed the first in human proof of concept one arm open label clinical trial of LAP-ST N22 followed by another small N7 pilot randomized double-blinded clinical trial for the feasibility safely and initial efficacy of LAP-ST and another group later confirmed the more favorable cognitive side effects of LAP-ST compared to higher current amplitude 800mA
However efficacy of LAP-ST against suicidality has not been well established as primary outcome previously
Thus this protocol proposes an initial randomized clinical trial that includes all patients with SI at baseline and with SI as the primary outcome measure to examine whether RUL LAP-ST treatment has more magnitude and rate of remission of SI as conventional pulse amplitude RUL ECT based on our prior secondary analysis Our central hypothesis is that RUL LAP-ST has significantly less cognitivememory side effects no memory side effects were noted in our prior studies for 500mA or 600mA and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT while maintaining better anti-suicidal effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None