Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02626832
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2015-11-04
Brief Title:
Regulation of Arginine-vasopressin AVP
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Regulation of Arginine-vasopressin AVP in Psychiatric Disorders
Status:
COMPLETED
Status Verified Date:
2015-12
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:
REGAVP
Brief Summary:
This study aims to develop a method for the assessment of central NMDA receptor functioning in patients with depression and schizophrenia For this purpose a transitional approach is used based on preclinical studies that show a dose-dependent relationship between the activity of hypothalamic NMDA receptor and plasma AVP response to increasing plasma osmolality Patients with schizophrenia depression and healthy controls participated in this study The Investigators found that in a subgroup of patients with schizophrenia the AVP response was low and that in a subgroup of subjects with depression the AVP response was high compared to healthy controls
Detailed Description:
Evidence suggests that altered N-methyl-D-aspartate NMDA receptor activity and glutamate signaling may underlie the pathogenesis of both schizophrenia and depression at least in subgroups of patients In schizophrenia pharmacologic modeling postmortem and imaging data suggest reduced NMDA signaling In contrast recent clinical trials demonstrating the efficacy of the NMDA antagonist ketamine in severely depressed patients suggest increased NMDA receptor signaling The Investigators have conducted a proof of concept study to assess whether there is any in vivo evidence for an inverse association in depression and schizophrenia with respect to the NMDA receptor function For this purpose the investigators used a translational approach based on findings from animal studies that NMDA receptor is a key mediator of arginine-vasopressin AVP release into the bloodstream Using hypertonic saline to induce AVP release as done in animal studies it was found that in a subgroup of depressed patients NMDA receptor mediated AVP release was significantly increased whereas in a subgroup of schizophrenia patients the same response was abnormally low Previous research has demonstrated that this response is well conserved These findings are consistent with implicated NMDA receptor related abnormalities in depression and schizophrenia in subgroups of patients and provide the first in vivo evidence towards this dichotomy
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