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NCT01799837 · ClinicalTrials.gov registry record · Phase 1
Norepinephrine Transporter Availability in PTSD
A Phase 1 study of Post Traumatic Stress Disorder, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01799837: Completed Phase 1 study of Post Traumatic Stress Disorder, sponsored by Emory University.
NCT01799837 is a Phase 1 study of Post Traumatic Stress Disorder that has completed, run by Emory University. The registered enrollment target is 9 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01799837, a Phase 1 study of Post Traumatic 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
Primary Outcome
Information to be obtained are \[11C\]MENET PET scans including arterial blood sampling to measure blood metabolites.\[11C\]MENET PET images will be analyze with a full compartmental kinetic analysis. Arterial blood and reference tissue input functions will be used to calculate the distribution volume ratio and binding potential of NET availability in each group
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 |
What the finished NCT01799837 record still lists
NCT01799837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which [C-11]MENET is the first listed.
NCT01799837 reports a single indexed study location in 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: Post Traumatic 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.
Learn More About Clinical Trials
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Where NCT01799837's enrollment target sits among peer trials
9 251st of 262 higher than 8 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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