Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04613453
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2020-10-27
Brief Title:
Reducing Adolescent Suicide Risk Safety Efficacy and Connectome Phenotypes of Intravenous Ketamine
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Reducing Adolescent Suicide Risk Safety Efficacy and Connectome Phenotypes of Intravenous Ketamine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if intravenous ketamine reduces suicidal thinking compared to an active placebo midazolam in adolescents who have treatment resistant depression and a recent history of a suicide event defined as a suicide attempt emergency room evaluation for suicidal thinking or a transition to inpatient care for suicidality in the past 120 days
The primary objective of this study is to determine whether ketamine reduces suicidal ideation as measured via the C-SSRS recent ideation scale relative to an active control midazolam 48-hours after first administration in adolescents with TRD at high suicide risk
The primary objective of this study is to determine whether ketamine reduces suicidal ideation as measured via the C-SSRS recent ideation scale relative to an active control midazolam 48-hours after first administration in adolescents with TRD at high suicide risk
Detailed Description:
The main purpose of the study is to examine the safety efficacy response predictors and post-treatment trajectory of adolescents with TRD and high suicide risk following a highly conservative repeat dosing ketamine infusion paradigm four infusions of 05mgkg each over two weeks compared to an active control midazolam Those who are randomized to midazolam and remain ill have the option to cross-over to ketamine in the open phase All participants will be followed closely for four months post-treatment and treated with standard of care depression treatment medication management and cognitive behavioral therapy Brain-based predictors of anti-suicidal responses will be assessed via connectome predictive modeling CPM examining functional brain circuits via fMRI before and after treatment
Given the unregulated use of ketamine in the community at widely varying doses and frequencies the safety data gathered from this highly conservative repeat dosing paradigm is critical to inform the field about potential risks Efficacy data at rapid short-term and intermediate-term 4 month timepoints will be critical to determining whether a larger study is warranted in this population The assessment of brain-based predictors of response through the integration of functional neuroimaging adds an important measure of biological engagement that will inform subsequent studies and stands to contribute towards the goal of personalized medicine ie determining not only if a treatment works but in whom
Aim 1 To evaluate the safety of treating adolescents with TRD at high suicide risk with a conservative repeat-dosing ketamine paradigm followed by standard of care treatment over 4 months Hypothesis We anticipate no untoward effects on medical outcomes cardiovascular function and bladder health or cognitive function measured via Cogstate
Aim 2 To evaluate the 48-hour impact of ketamine on suicidal ideation compared to midazolam and to identify connectome phenotypes predictive of ideation post-treatment Hypothesis Ketamine will reduce suicidal thinking Columbia Suicide Rating Scale recent ideation subscale compared to midazolam CPM will identify networks predictive of ideation validated via k-fold or leave-one-out cross-validation within the sample The network measures obtained at this fixed ketamine dose will inform the design of larger clinical trials
Aim 3 exploratory To describe the trajectory of suicidal thinking depressive symptoms and use of mental health resources in both ketamine responders and non-responders over 4 months
Given the unregulated use of ketamine in the community at widely varying doses and frequencies the safety data gathered from this highly conservative repeat dosing paradigm is critical to inform the field about potential risks Efficacy data at rapid short-term and intermediate-term 4 month timepoints will be critical to determining whether a larger study is warranted in this population The assessment of brain-based predictors of response through the integration of functional neuroimaging adds an important measure of biological engagement that will inform subsequent studies and stands to contribute towards the goal of personalized medicine ie determining not only if a treatment works but in whom
Aim 1 To evaluate the safety of treating adolescents with TRD at high suicide risk with a conservative repeat-dosing ketamine paradigm followed by standard of care treatment over 4 months Hypothesis We anticipate no untoward effects on medical outcomes cardiovascular function and bladder health or cognitive function measured via Cogstate
Aim 2 To evaluate the 48-hour impact of ketamine on suicidal ideation compared to midazolam and to identify connectome phenotypes predictive of ideation post-treatment Hypothesis Ketamine will reduce suicidal thinking Columbia Suicide Rating Scale recent ideation subscale compared to midazolam CPM will identify networks predictive of ideation validated via k-fold or leave-one-out cross-validation within the sample The network measures obtained at this fixed ketamine dose will inform the design of larger clinical trials
Aim 3 exploratory To describe the trajectory of suicidal thinking depressive symptoms and use of mental health resources in both ketamine responders and non-responders over 4 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH125203-01 | NIH | None | httpsreporternihgovquickSearch1R01MH125203-01 |