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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00069212 |
Purpose
This study will evaluate brain changes and psychological characteristics of people who are resilient to trauma. It will examine and compare responses in three categories of subjects: 1) people who have been exposed to a significant traumatic event and suffer symptoms of post-traumatic stress disorder (PTSD) severe enough to interfere with their ability to function; 2) people who have been exposed to a significant traumatic event and do not suffer PTSD symptoms severe enough to interfere with their ability to function; and 3) people who have never been exposed to a significant traumatic event. Most people who are exposed to trauma recover well from the adversity. Some may even benefit from it by, for example, gaining greater self-confidence of strengthening personal relationships. Others, however, develop PTSD and may have repeated thoughts, images, and dreams of the trauma; feel upset when reminded of the traumatic event; avoid places or people that remind them of the trauma; feel detached from others; have difficulty sleeping and concentrating; or startle easily.
People in the three categories listed above may be eligible for this study. Candidates will be screened with a medical and psychiatric interview, evaluation of emotional intelligence (sensitivity to feelings of others), physical examination, electrocardiogram (EKG) and blood tests.
Participants will undergo the following additional tests and procedures:
| Condition |
|---|
|
Stress Disorders, Post-Traumatic |
| Study Type: | Observational |
| Official Title: | Psychobiological Mechanisms of Resilience to Trauma |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2003 |
Since the majority of research studies in posttraumatic stress disorder (PTSD) have focused on the pathological consequences of exposure to trauma, there is a paucity of information on the psychobiology of subjects who are resilient to severe stress. The proposed study will comprehensively evaluate the neural circuits that mediate fear, reward, social cooperation, memory, and emotional regulation in traumatized men and women with and without PTSD and healthy subjects. Subject groups will include prisoners of war, active duty special operations forces, returning Iraqi veterans (approval pending), and men and women exposed to non-combat traumas including sexual and or physical abuse. Comparison groups will include men and momen exposed to trauma without PTSD (resilient subjects), and healthy men and women who have never been exposed to trauma. Changes in neural circuitry associated with resilience will be evaluated using functional magnetic resonance imaging (fMRI). Relationships and interactions among the neural circuits mediating fear, reward, social cooperation, memory, and emotional regulation will be assessed and correlated with clinical, neuroendocrine, and neuropsychological findings. Identification of biological and psychosocial correlates of resilience could help predict illness vulnerability following exposure to trauma and could assist in the selection of "hardy" subjects for high-risk professions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Over 18 years of age.
Able to give written informed consent prior to participation in this study.
Not currently on medications for PTSD or other medications that would interfere with cognitive function. (Patients will not be discontinued from effective medication for purposes of the study).
Nonresponders to other psychotropic drugs must have discontinued them for at least 2 weeks prior to the first fMRI scan. Medications will be discontinued under the supervision of the subject's treating psychiatrist or primary care physician. (Nonresponders will be defined as subjects who continue to meet criteria for PTSD despite treatment with 30 mg equivalent or greater of paroxetine for a minimum duration of six weeks).
In good physical health as confirmed by a complete physical exam (including normal vital signs), electrocardiogram, neurological exam, and routine laboratory tests of blood and urine. However, if subjects participated in other research studies or had blood work through their primary MD within the prior 6 months, these results will be used instead of repeating blood draws for inclusion into the study. Subjects with stable medical problems will be included.
Resilient subjects or trauma controls will be defined as those subjects who met criteria for significant trauma according to "A" criteria for PTSD (DSM-IV) but did not develop PTSD symptoms.
EXCLUSION CRITERIA:
Have a clinically significant or unstable medical disorder.
Meet DSM-IV criteria for alcohol and/or substance abuse or substance dependence within 6 months prior to screening.
Currently on fluoxetine (justification: washout from fluoxetine could take up to six weeks).
Currently at high risk for homicide or suicide.
A current or past history of other Axis 1 disorders such as schizophrenia, schizoaffective disorder, bipolar disorder. However, those with a comorbid history of other Axis 1 disorders such as major depression, dysthymia, or panic disorder will be included. (Justification: approximately 70% of subjects with PTSD have comorbid depression and or alcohol abuse (Breslau 2001). Restricting the sample to PTSD patients without depression would not accurately reflect the biology of this disorder).
Have donated a Red Cross unit of blood within 60 days prior to study participation.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, District of Columbia | |
| Howard University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20060 | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20301 | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 030292, 03-M-0292 |
| Study First Received: | September 17, 2003 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00069212 |
| Health Authority: | United States: Federal Government |
|
Post-Traumatic Stress Disorder Neural Circuits Fear Emotional Regulation |
Reward PTSD Post-Traumatic Stress Disorder |
|
Anxiety Disorders Mental Disorders Wounds and Injuries |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
