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NCT01799837 · ClinicalTrials.gov registry record · Phase 1
Norepinephrine Transporter Availability in PTSD
A Phase 1 study of Posttraumatic Stress Disorder, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01799837 is a Phase 1 study of Posttraumatic Stress Disorder that has completed, run by Emory University. The registered enrollment target is 9 participants, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01799837, a Phase 1 study of Posttraumatic Stress Disorder, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this proposal is to collect pilot data to characterize the binding of \[11C\]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care. Little is known about the dysregulation of PTSD veteran's neurochemical state including the noradrenergic system which plays a primary role in memory and stress response. This includes heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is responsible for regulating and terminating noradrenergic transmission, and is a specific marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET protein. An unresolved problem in studying the noradrenergic system is identification of suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The investigators propose to address this challenge by using positron emission tomography (PET) to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD. The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system compared to healthy controls. Through a series of experiments, the investigators will determine the in vivo binding characteristics of \[11C\]MENET. The investigators will use this information to optimally design an experimental protocol to measure the availability of NET in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1) Measure t
Conditions Studied
Interventions
- DRUG [C-11]MENET
Study Locations (1)
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01799837
The ClinicalTrials.gov registry entry for NCT01799837 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (92% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which [C-11]MENET is the first listed.
NCT01799837 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT01799837 about?
NCT01799837 is a clinical study titled "Norepinephrine Transporter Availability in PTSD". The objective of this proposal is to collect pilot data to characterize the binding of \[11C\]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of ...
What is the current status of trial NCT01799837?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-06. Estimated completion is 2013-07.
What conditions does trial NCT01799837 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT01799837?
The interventions under investigation include: [C-11]MENET (DRUG).
Who is sponsoring clinical trial NCT01799837?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01799837 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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