Ignite Creation Date:
2024-05-05 @ 10:43 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01179009
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2010-08-02
Brief Title:
Treatment Resistant Depression Pilot
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Safe Ketamine-Based Therapy for Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Treatment resistant depression TRD is a major public health problem Current therapeutic options for this patient population remain limited With all available treatments only a sub-set of those patients who achieve an antidepressant response are likely to achieve treatment-induced remission The need for antidepressant medication that can provide both rapid and long lasting relief of TRD symptoms is widely recognized There is new evidence that drugs that block NMDA glutamate receptors NMDA antagonists are promising candidates for meeting this need Existing studies in TRD have used only a low-dose brief infusion of ketamine that would not be expected to re-sensitize the NMDA receptor in agreement with this theory these prior studies have found only temporary improvements of depression Our key hypothesis is that a higher-dose longer-term ketamine infusion such as that used in chronic pain studies would provide a more robust and lasting improvement from depression
Accordingly we will test whether a 100-hour ketamine infusion would be more effective than the standard 40-minute ketamine infusion currently used in other TRD studies We will randomize subjects to one of 2 arms 1 100-hour - 4 hours ketamine infusion plus clonidine for the entire infusion 2 40-minute ketamine infusion plus clonidine following a 100- hour saline infusion All subjects will receive clonidine an alpha-2 agonist to minimize side effects of ketamine namely briefmild psychotic and cognitive symptoms
Accordingly we will test whether a 100-hour ketamine infusion would be more effective than the standard 40-minute ketamine infusion currently used in other TRD studies We will randomize subjects to one of 2 arms 1 100-hour - 4 hours ketamine infusion plus clonidine for the entire infusion 2 40-minute ketamine infusion plus clonidine following a 100- hour saline infusion All subjects will receive clonidine an alpha-2 agonist to minimize side effects of ketamine namely briefmild psychotic and cognitive symptoms
Detailed Description:
This experiment is a pilot study involving up to 20 healthy males or females between the ages of 18-65 to test whether a 100-hour ketamine infusion plus clonidine would be more effective with longer lasting results then the standard 40-minute ketamine infusion plus clonidine Each of the 2 arms will be evaluated using a between subject double-blind randomized design
1 a Controlled up to 100-hour IV ketamine infusion b clonidine safener PO prior to infusion
2 a Controlled 40-minute IV ketamine infusion b clonidine safener PO prior to infusion c up to 100-hour-IV placebo saline infusion
3 a Controlled up to 100-hour IV ketamine infusion b clonidine safener PO prior to infusion
4 aControlled up to 100-hour IV ketamine infusion b clonidine safener PO prior to infusion
In both conditions participants will be admitted to the Washington University School of Medicine Clinical Research Unit at Barnes-Jewish Hospital for approximately 108-hours Monday morning-Friday evening Pulse blood pressure pulse-oximetry and an electrocardiogram strip will be routinely monitored Serial labs and clinicalsafety ratings will be done pre- during and post-infusion with the last assessments being used to assure that subjects have returned to their baseline prior to discharge from the research unit Participants will continue to see their primary psychiatrist throughout the study
1 a Controlled up to 100-hour IV ketamine infusion b clonidine safener PO prior to infusion
2 a Controlled 40-minute IV ketamine infusion b clonidine safener PO prior to infusion c up to 100-hour-IV placebo saline infusion
3 a Controlled up to 100-hour IV ketamine infusion b clonidine safener PO prior to infusion
4 aControlled up to 100-hour IV ketamine infusion b clonidine safener PO prior to infusion
In both conditions participants will be admitted to the Washington University School of Medicine Clinical Research Unit at Barnes-Jewish Hospital for approximately 108-hours Monday morning-Friday evening Pulse blood pressure pulse-oximetry and an electrocardiogram strip will be routinely monitored Serial labs and clinicalsafety ratings will be done pre- during and post-infusion with the last assessments being used to assure that subjects have returned to their baseline prior to discharge from the research unit Participants will continue to see their primary psychiatrist throughout the study
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