Post-Traumatic Stress DisordersNCT00039715
Effects of Hydrocortisone in Patients With Post-Traumatic Stress Disorder
An observational study of Post-Traumatic Stress Disorders and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether people who develop Post-Traumatic Stress Disorder (PTSD) after a trauma have increased sensitivity to the effects of a stress hormone. Patients with PTSD have small hippocampal volume and deficits in hippocampal-mediated memory as compared to healthy people. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorders, Healthy
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Sep 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The study sample will consist of:
- Patients with a primary diagnosis of PTSD due to non-combat or combat related trauma according to DSM-IV.
- Subjects with non-combat related traumatic experiences without current PTSD and
- Healthy subjects without current or past history of psychiatric or major medical illness.
- All subjects will be between 18 and 60 years old.
- Male and female subjects will be included.
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- All subjects must be able to give written informed consent prior to participation in this study.
- Patients with PTSD must score greater than or equal to 50 on Clinician-Administered PTSD Scale as a measure of PTSD symptom severity to be included in the study.
- Patients who are not currently on medications for PTSD. (Patients will not be discontinued from effective medication for purposes of the study).
- Patients who are nonresponders to other psychotropic drugs must have discontinued them for at least 2 weeks prior to the first PET scan. Medications will be discontinued under the supervision of the treating physician or a research psychiatrist listed in the protocol. (Nonresponders will be defined as subjects who continue to meet criteria for PTSD despite treatment with 30 mg equivalent of paroxetine for a minimum duration of six weeks).
- 7. All eligible subjects must be 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 patients have participated in other research studies or have had blood work through their primary MD within the last 6 months, these results will be used instead of repeating blood draws for inclusion into the study.]
Who cannot join
- Subjects with a clinically significant cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder.
- Patients who would be unable to comply with study procedures or assessments.
- Subjects with primary trauma related to motor vehicle accidents.
- Patients who meet DSM-IV criteria for alcohol and/or substance abuse or substance dependence within 6 months prior to screening.
- Patients who are currently on fluoxetine (Justification: Washout from fluoxetine could take up to six weeks).
- Patients who are currently at high risk for homicide or suicide.
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- Subjects with a current or past history of other axis I disorders like schizophrenia, schizoaffective disorder, bipolar disorder or dementia will be excluded from the study. However, those with a comorbid history of other Axis 1 disorder like major depression, dysthymia or panic disorder will be included in the study. Justification: Approximately 70% of subjects with PTSD have comorbid depression and or alcohol abuse; reviewed in 134. Restricting the sample to PTSD patients without depression will not accurately reflect the biology of this disorder].
- Subjects with a history of peptic ulcer disease will be excluded. (Justification: Those with a history of acid peptic disease requiring antacids in the past will be excluded, although it is unlikely that a single dose of intravenous hydrocortisone could precipitate bleeding due to gastritis or peptic ulcer disease).
- Women of childbearing potential who are not practicing a clinically accepted method of contraception or who have a positive pregnancy test or who are lactating.
- Subjects who donated a Red Cross unit of blood within 60 days prior to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Effect of Hydrocortisone Infusion on Hippocampal Glucose Metabolism, Neuropsychological Test Performance and Reexperiencing Symptoms in Patients With Post-Traumatic Stress Disorder (PTSD)
The purpose of this study is to determine whether people who develop Post-Traumatic Stress Disorder (PTSD) after a trauma have increased sensitivity to the effects of a stress hormone.
Patients with PTSD have small hippocampal volume and deficits in hippocampal-mediated memory as compared to healthy people. However, it is unclear whether the smaller hippocampi are a consequence of PTSD or a risk factor for the development of PTSD. Some researchers believe that people who develop PTSD have an increase in cortisol levels during traumatic experiences and that this could be neurotoxic to the hippocampus. Others hypothesize that increased sensitivity of glucocorticoid receptors to cortisol, regardless of the cortisol levels, could lead to neurotoxic damage to the hippocampus. This study will compare responses to a stress hormone in patients with PTSD, participants who have experienced trauma but do not have PTSD, and healthy volunteers.
Read more
Participants will be screened with a medical and psychiatric interview, physical examination, blood tests, electrocardiogram, and an emotional intelligence evaluation. Those eligible for the study will be asked to collect urine and saliva samples for 3 days. Participation will also include blood draws, a PET scan (brain imaging), an eye-blink test, neuropsychological testing, and other procedures.
At another study visit, participants will undergo a magnetic resonance imaging (MRI) scan (brain imaging), questionnaires, and other procedures.
Read the detailed description
Patients with post traumatic stress disorder (PTSD) related to combat or civilian trauma have been found to have small hippocampal volume, and deficits in hippocampal mediated memory, compared to the controls. However, it is not clear if the smaller hippocampi are a consequence of the extreme trauma and PTSD, or a risk factor in the development of PTSD. Researchers supporting the causal hypothesis have proposed that increased levels of cortisol during the traumatic experience could be neurotoxic to the hippocampus. Several studies have confirmed an increase in levels of cortisol during stress. However, plasma and urine measures of cortisol in patients with PTSD are mixed; with reports of increased decreased or normal cortisol. The possibility that increased sensitivity of the Type II or glucocorticoid receptors to circulating cortisol could lead to neurotoxic damage to the hippocampus, despite normal to low peripheral levels of cortisol has been proposed. Furthermore, increased sensitivity of the glucocorticoid receptor in PTSD could lead to stronger negative feedback inhibition, thereby offering a mechanism for the paradoxical observation of lower ACTH and cortisol levels in PTSD. Studies attempting to test the glucocorticoid receptor super sensitivity theory in PTSD confirmed the presence of increased number and sensitivity of lymphocyte glucocorticoid receptors in patients compared to healthy subjects. However, there are currently no published reports investigating central glucocorticoid sensitivity in patients with PTSD. A recent study in healthy subjects and Alzheimer's disease demonstrated that central glucocorticoid receptor sensitivity can be measured by hydrocortisone mediated inhibition of glucose metabolism measured by positron emission tomography (PET) and 2-deoxy-2[F]fluoro-D-glucose (FDG). We propose to evaluate the metabolic, cognitive, and behavioral effects of hydrocortisone or placebo administration in patients with PTSD, subjects who have experienced trauma but do not develop PTSD (trauma controls) and healthy subjects.
- Conditions
- Post-Traumatic Stress Disorders, Healthy
- Keywords
- Glucocorticoid Receptor, Traumatic Reminders, Stress, Hippocampus, Flashbacks, PTSD, Type II GR Receptor, Hydrocortisone, Memory, Major Depression, Post-Traumatic Stress Disorder, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2002 (estimated)
- Study startJun 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 93 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039715
- Sponsor's protocol ID
- 020209
- Other IDs
- 02-M-0209
- Status last verified
- Sep 2004
- First submitted
- 6 Jun 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bremner JD, Randall P, Scott TM, Capelli S, Delaney R, McCarthy G, Charney DS. Deficits in short-term memory in adult survivors of childhood abuse. Psychiatry Res. 1995 Nov 29;59(1-2):97-107. doi: 10.1016/0165-1781(95)02800-5.
PubMed 8771224Bremner JD, Randall P, Scott TM, Bronen RA, Seibyl JP, Southwick SM, Delaney RC, McCarthy G, Charney DS, Innis RB. MRI-based measurement of hippocampal volume in patients with combat-related posttraumatic stress disorder. Am J Psychiatry. 1995 Jul;152(7):973-81. doi: 10.1176/ajp.152.7.973.
PubMed 7793467Bremner JD, Randall P, Vermetten E, Staib L, Bronen RA, Mazure C, Capelli S, McCarthy G, Innis RB, Charney DS. Magnetic resonance imaging-based measurement of hippocampal volume in posttraumatic stress disorder related to childhood physical and sexual abuse--a preliminary report. Biol Psychiatry. 1997 Jan 1;41(1):23-32. doi: 10.1016/s0006-3223(96)00162-x.
PubMed 8988792
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrocortisone Infusion on Hippocampal Glucose Metabolism, Neuropsychological Test Performance and Reexperiencing Symptoms in Patients With Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00039715
- Acronym / sponsor ID
- 020209
- Conditions
- Post-Traumatic Stress Disorders, Healthy
- Keywords
- Glucocorticoid Receptor, Traumatic Reminders, Stress, Hippocampus, Flashbacks, PTSD, Type II GR Receptor, Hydrocortisone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- Sep 2004
- First posted
- 7 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether people who develop Post-Traumatic Stress Disorder (PTSD) after a trauma have increased sensitivity to the effects of a stress hormone.
Patients with PTSD have small hippocampal volume and deficits in hippocampal-mediated memory as compared to healthy people. However, it is unclear whether the smaller hippocampi are a consequence of PTSD or a risk factor for the development of PTSD. Some researchers believe that people who develop PTSD have an increase in cortisol levels during traumatic experiences and that this could be neurotoxic to the hippocampus. Others hypothesize that increased sensitivity of glucocorticoid receptors to cortisol, regardless of the cortisol levels, could lead to neurotoxic damage to the hippocampus. This study will compare responses to a stress hormone in patients with PTSD, participants who have experienced trauma but do not have PTSD, and healthy volunteers.
Participants will be screened with a medical and psychiatric interview, physical examination, blood tests, electrocardiogram, and an emotional intelligence evaluation. Those eligible for the study will be asked to collect urine and saliva samples for 3 days. Participation will also include blood draws, a PET scan (brain imaging), an eye-blink test, neuropsychological testing, and other procedures.
At another study visit, participants will undergo a magnetic resonance imaging (MRI) scan (brain imaging), questionnaires, and other procedures.
Detailed description
Patients with post traumatic stress disorder (PTSD) related to combat or civilian trauma have been found to have small hippocampal volume, and deficits in hippocampal mediated memory, compared to the controls. However, it is not clear if the smaller hippocampi are a consequence of the extreme trauma and PTSD, or a risk factor in the development of PTSD. Researchers supporting the causal hypothesis have proposed that increased levels of cortisol during the traumatic experience could be neurotoxic to the hippocampus. Several studies have confirmed an increase in levels of cortisol during stress. However, plasma and urine measures of cortisol in patients with PTSD are mixed; with reports of increased decreased or normal cortisol. The possibility that increased sensitivity of the Type II or glucocorticoid receptors to circulating cortisol could lead to neurotoxic damage to the hippocampus, despite normal to low peripheral levels of cortisol has been proposed. Furthermore, increased sensitivity of the glucocorticoid receptor in PTSD could lead to stronger negative feedback inhibition, thereby offering a mechanism for the paradoxical observation of lower ACTH and cortisol levels in PTSD. Studies attempting to test the glucocorticoid receptor super sensitivity theory in PTSD confirmed the presence of increased number and sensitivity of lymphocyte glucocorticoid receptors in patients compared to healthy subjects. However, there are currently no published reports investigating central glucocorticoid sensitivity in patients with PTSD. A recent study in healthy subjects and Alzheimer's disease demonstrated that central glucocorticoid receptor sensitivity can be measured by hydrocortisone mediated inhibition of glucose metabolism measured by positron emission tomography (PET) and 2-deoxy-2[F]fluoro-D-glucose (FDG). We propose to evaluate the metabolic, cognitive, and behavioral effects of hydrocortisone or placebo administration in patients with PTSD, subjects who have experienced trauma but do not develop PTSD (trauma controls) and healthy subjects.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- The study sample will consist of:
- Patients with a primary diagnosis of PTSD due to non-combat or combat related trauma according to DSM-IV.
- Subjects with non-combat related traumatic experiences without current PTSD and
- Healthy subjects without current or past history of psychiatric or major medical illness.
- All subjects will be between 18 and 60 years old.
Key exclusion criteria (10 listed)
- Subjects with a clinically significant cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder.
- Patients who would be unable to comply with study procedures or assessments.
- Subjects with primary trauma related to motor vehicle accidents.
- Patients who meet DSM-IV criteria for alcohol and/or substance abuse or substance dependence within 6 months prior to screening.
- Patients who are currently on fluoxetine (Justification: Washout from fluoxetine could take up to six weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8771224Bremner JD, Randall P, Scott TM, Capelli S, Delaney R, McCarthy G, Charney DS. Deficits in short-term memory in adult survivors of childhood abuse. Psychiatry Res. 1995 Nov 29;59(1-2):97-107. doi: 10.1016/0165-1781(95)02800-5.
- Background: PubMed 7793467Bremner JD, Randall P, Scott TM, Bronen RA, Seibyl JP, Southwick SM, Delaney RC, McCarthy G, Charney DS, Innis RB. MRI-based measurement of hippocampal volume in patients with combat-related posttraumatic stress disorder. Am J Psychiatry. 1995 Jul;152(7):973-81. doi: 10.1176/ajp.152.7.973.
- Background: PubMed 8988792Bremner JD, Randall P, Vermetten E, Staib L, Bronen RA, Mazure C, Capelli S, McCarthy G, Innis RB, Charney DS. Magnetic resonance imaging-based measurement of hippocampal volume in posttraumatic stress disorder related to childhood physical and sexual abuse--a preliminary report. Biol Psychiatry. 1997 Jan 1;41(1):23-32. doi: 10.1016/s0006-3223(96)00162-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorders and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00039715, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 7 Nov 2026.