Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088738
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-07-30
Brief Title:
Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With 18FSPA-RQ
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With 18F SPA-RQ
Status:
COMPLETED
Status Verified Date:
2008-09-10
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:
This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder and thereby further our understanding of its role in this illness We will measure levels of Substance P in the brain by obtaining pictures of the brain using PET and MRI
Detailed Description:
The involvement of Substance P SP in depression and anxiety has been credibly demonstrated in a recent clinical trial Although the precise physiological activation mechanism of the SP system is not yet known the likelihood of exaggerated SP pathway activity in the pathogenesis of anxiety is supported in numerous animal studies that illustrate the anxiogenic and anxiolytic effects of SP and SP antagonists SPAs respectively Studies have further shown that SP release occurs in response to noxious or aversive stimulation SP stimulates NK1 receptors that then undergo endocytosis ie internalization resulting in a decrease in number of NK1 receptors on the cell surface NK1 receptor quantification before and after an aversive event provides a dynamic measurement of SP neurotransmission
In this protocol we will use a new PET ligand that has demonstrated ability to serve as an NK1 receptor antagonist 18FSPA-RQ 18F-labeled Substance P Antagonist Receptor Quantifier Using this tracer we will 1 quantify NK1 binding parameters and determine the reliability and reproducibility of these measures in 10 healthy controls 2 we will look for regional differences in NK1 receptor binding in 10 patients with panic disorder PD versus 10 normal controls and 3 We will perform a single-blind placebo-controlled study to evaluate NK1 receptor binding in PD patients and controls following either saline or doxapram infusion which is a respiratory stimulant in 20 patients with panic disorder PD versus 20 normal controls Doxapram acts on both peripheral and medullary chemoreceptors to increase the rate and depth of breathing It appears to be a potent and specific panicogenic agent triggering panic attacks The majority of PD patients but not controls are expected to experience a panic attack aversive event following the doxapram infusion Comparison of pre-panic and post-panic NK1 receptor binding in PD patients will provide an estimate of SP release The goal of the present study is to demonstrate the involvement of SP in panic disorder and thereby further our understanding of its role in the psychopathology of this illness
In this protocol we will use a new PET ligand that has demonstrated ability to serve as an NK1 receptor antagonist 18FSPA-RQ 18F-labeled Substance P Antagonist Receptor Quantifier Using this tracer we will 1 quantify NK1 binding parameters and determine the reliability and reproducibility of these measures in 10 healthy controls 2 we will look for regional differences in NK1 receptor binding in 10 patients with panic disorder PD versus 10 normal controls and 3 We will perform a single-blind placebo-controlled study to evaluate NK1 receptor binding in PD patients and controls following either saline or doxapram infusion which is a respiratory stimulant in 20 patients with panic disorder PD versus 20 normal controls Doxapram acts on both peripheral and medullary chemoreceptors to increase the rate and depth of breathing It appears to be a potent and specific panicogenic agent triggering panic attacks The majority of PD patients but not controls are expected to experience a panic attack aversive event following the doxapram infusion Comparison of pre-panic and post-panic NK1 receptor binding in PD patients will provide an estimate of SP release The goal of the present study is to demonstrate the involvement of SP in panic disorder and thereby further our understanding of its role in the psychopathology of this illness
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-M-0189 | None | None | None |