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NCT01031979 · ClinicalTrials.gov registry record · Phase 2
Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) With/Without Yohimbine
A Phase 2 study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01031979: Completed Phase 2 study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
NCT01031979 is a Phase 2 study of Post Traumatic Stress Disorder that has completed, run by VA Office of Research and Development. The registered enrollment target is 26 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031979, a Phase 2 study of Post Traumatic Stress Disorder, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study has three distinct but related research objectives. The first goal is to measure physiological correlates of successful treatment with Prolonged Exposure (PE) therapy for posttraumatic stress disorder (PTSD) in veterans of the Iraq and Afghanistan wars. Individuals with PTSD often experience elevated heart rates and other objectively measurable signs of anxiety when confronted with safe situations that remind them of past dangerous situations. We will measure physiological responses and compare the outcomes to patient's self reported subjective accounts of symptom improvement on traditional measures of PTSD. Developing a way to measure objective gains in symptoms improvement may help researchers who are studying ways to improve PTSD treatment. The second goal of the study is to investigate if yohimbine, a drug found to promote a specific type of learning, will improve treatment outcomes for veterans in PTSD treatment. The third goal is to investigate if ability to get used to loud startling audio tones correlates to baseline PTSD pathology and treatment outcomes for PE. This goal represents an important step forward in understanding characteristics of heritable traits that are related PTSD. It is significant because such research may one day lead to the development of individual responder policies that will assist patients by individualizing treatment plans based on personal characteristics.
Primary Outcome
The primary outcome was trauma-cued heart rate reactivity a week after the drug visit as measured by the PTSD Brief Reactivity (PBR) task. For each patient, a 3-minute trauma script was constructed containing vivid details of the target trauma and used in tandem with a standard neutral script for baseline measurement. Heart rate reactivity for each time point was the beats per minute (BPM) difference between the neutral and trauma scripts represented as a slope.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Yohimbine
Study Locations (1)
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-12-01 |
| Est. Completion | 2015-07-07 |
| Phase | Phase 2 |
What the finished NCT01031979 record still lists
NCT01031979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01031979 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT01031979 about?
NCT01031979 is a clinical study titled "Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) With/Without Yohimbine". The proposed study has three distinct but related research objectives. The first goal is to measure physiological correlates of successful treatment with Prolonged Exposure (PE) therapy for posttraumatic stress disorder (PTSD) in veterans of the Iraq and Afghanistan wars. Individuals with PTSD often...
What is the current status of trial NCT01031979?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-12-01. Estimated completion is 2015-07-07.
What conditions does trial NCT01031979 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT01031979?
The interventions under investigation include: Placebo (DRUG), Yohimbine (DRUG).
Who is sponsoring clinical trial NCT01031979?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01031979 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01031979's enrollment target sits among peer trials
26 222nd of 262 higher than 40 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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