CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
Dexamethasone +1 moredrug
Likely dose
Dexamethasone 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01477762
NCT01477762N/ACompleted

Effects of Cortisol Suppression on Fear-Potentiated Startle in Traumatized Individuals With and Without PTSD

Emory University·interventional·Posted Nov 23, 2011·Updated Apr 18, 2017

In Brief

A clinical study evaluating Dexamethasone and Placebo for Post Traumatic Stress Disorder. Completed, enrolled 165 participants across 1 site.

Detailed Summary

Posttraumatic stress disorder (PTSD) occurs in some people after exposure to events that cause extreme fear or helplessness. The incidence of war zones worldwide and the prevalence of violence in large cities in the U.S., increases the likelihood that people will experience a traumatizing event in their lifetime. About 1 in 10 people who survive such events will develop PTSD, while most people will get better over time. This suggests that some people may have biological vulnerabilities that make it harder for them to recover. One of these biological risk factors may be related to how stress hormones work in people who get sick. Another is how people react to things that make them afraid or nervous, investigators have found that PTSD patients have higher than normal fear reactions. The part of the brain that reacts to fearful stimulation is linked to stress hormones; the purpose of this study is to examine how these systems interact. The study will suppress stress hormones (cortisol) production in one group of participants, while another will get a placebo. When their cortisol is suppressed, the participants will undergo a startle study to see if their fear responses are decreased. Investigators expect that people PTSD will show a normal fear response when their cortisol levels are reduced, similar to people without PTSD. This research can help discover new medicines for people with PTSD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 23, 2011
Enrollment StartNov 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.6 years ago

Interventions

Dexamethasonedrug

One tablet of 0.5 mg dexamethasone will be taken ten hours prior to completing study assessments.

Placebodrug

One placebo tablet will be taken ten hours prior to completing study assessments.