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N/A N=91 Randomized Triple-blind Basic Science

Cortisol Suppression and Startle Responses in Posttraumatic Stress Disorder (PTSD)

Post Traumatic Stress Disorder

Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Mean Baseline Startle Magnitude During Fear Conditioning — 48.401; 56.595; 115.778; 57.684 microvolts

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Dexamethasone (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Emory University
Primary completion
Jul 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Baseline Startle Magnitude During Fear Conditioning
48.401; 56.595; 115.778; 57.684; 42.842; 72.072
PRIMARY
Mean Startle Magnitude to Danger Signal During Fear Conditioning
98.734; 94.912; 143.360; 76.294; 80.825; 113.208
PRIMARY
Mean Fear-potentiated Startle to Danger Signal During Early Extinction
29.211; 17.328; 33.404; 37.099; 18.715; 25.119
PRIMARY
Mean Fear-potentiated Startle to Danger Signal During Late Extinction
1.620; -7.824; 30.858; 13.369; -1.867; -10.440

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.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent
  • Willing to participate in initial assessment and 2 full days of interviews and imaging visit
  • Able to understand English and no obvious deficit in comprehension or following directions
  • 18-65 years old

Exclusion Criteria

  • Mental Retardation (per clinical judgment of study physician)
  • Psychotic Disorder (per clinical judgment of study physician)
  • Acute suicidal ideation
  • Pregnancy
  • Positive urine drug screen
  • Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01477762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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