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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 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 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Post Traumatic Stress Disorder

Interventions

  • DRUG Placebo
  • DRUG Yohimbine

Study Locations (1)

South Carolina

  • Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-12-01
Est. Completion 2015-07-07
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

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What the Registry Record Tells You About NCT01031979

The ClinicalTrials.gov registry entry for NCT01031979 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.