Post Traumatic Stress DisorderNCT01525680
A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
A study testing Hydrocortisone augmented Prolonged Exposure Therapy in people with Post Traumatic Stress Disorder, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Hydrocortisone augmented Prolonged Exposure Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2015
- Phase
- Interventional
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 89
- Capable of understanding, reading, and writing in English
- OIF/OEF veteran with criterion-A trauma while deployed
- Minimum PTSD severity of 60 (CAPS)
- Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)
Who cannot join
- Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder
- Moderate or severe traumatic brain injury (TBI)
- A medical or mental health problem other than PTSD that requires immediate clinical attention
- Substance abuse or dependence within the last 3 months
- Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment
- Persons on a psychotropic medication regimen that has not been consistent for one month
Show all 9Show fewer
- Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance)
- Unwillingness to discontinue other specialized psychotherapy for PTSD during the 11 weeks of study treatment and the 3 month follow-up (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated)
- Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
Rachel Yehuda, PhD, rachel.yehuda@va.gov
About this study
Official title: Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Hydrocortisone augmented Prolonged Exposure Therapy, Prolonged exposure therapy with placebo administration
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone augmented Prolonged Exposure TherapyOther
11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
Prolonged exposure therapy with placebo administrationOther
11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure therapy with Hydrocortisone | Active comparator | Not described Receives: Other: Hydrocortisone augmented Prolonged Exposure Therapy |
| Prolonged Exposure therapy with placebo | Placebo comparator | Not described Receives: Other: Prolonged exposure therapy with placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Measured: week 0
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Measured: week 12
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Measured: week 23
Secondary outcomes (9)
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Measured: week 0
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Measured: week 12
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Measured: week 23
MATRICS Consensus Cognitive Battery (MCCB)
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Measured: week 0
MATRICS Consensus Cognitive Battery (MCCB)
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Measured: week 12
MATRICS Consensus Cognitive Battery (MCCB)
Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.
Measured: week 23
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Measured: week 0
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Measured: week 12
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Measured: week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Rachel Yehuda, Bronx VA Medical Center
- Investigators
- Rachel Yehuda, PhD, Principal investigator, James J Peters VAMC/Mount Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525680
- Sponsor's protocol ID
- YEH-09-087
- Status last verified
- Nov 2013
- First submitted
- 1 Feb 2012
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"
- ClinicalTrials.gov ID
- NCT01525680
- Acronym / sponsor ID
- YEH-09-087
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Apr 2011
- Primary completion
- Sep 2015 (estimated)
- First posted
- 3 Feb 2012 (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.
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure therapy with Hydrocortisone | Active comparator | Other: Hydrocortisone augmented Prolonged Exposure Therapy |
| Prolonged Exposure therapy with placebo | Placebo comparator | Other: Prolonged exposure therapy with placebo administration |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 89
- Capable of understanding, reading, and writing in English
- OIF/OEF veteran with criterion-A trauma while deployed
- Minimum PTSD severity of 60 (CAPS)
- Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)
Key exclusion criteria (9 listed)
- Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder
- Moderate or severe traumatic brain injury (TBI)
- A medical or mental health problem other than PTSD that requires immediate clinical attention
- Substance abuse or dependence within the last 3 months
- Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone augmented Prolonged Exposure Therapy11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered. | Other | Prolonged Exposure therapy with Hydrocortisone |
| Prolonged exposure therapy with placebo administration11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered. | Other | Prolonged Exposure therapy with placebo |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: week 0
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Clinician Administered PTSD Scale (CAPS)
Time frame: week 12
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Clinician Administered PTSD Scale (CAPS)
Time frame: week 23
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
9 secondary outcomes
Biological measures associated with PTSD
Time frame: week 0
Biological measures associated with PTSD
Time frame: week 12
Biological measures associated with PTSD
Time frame: week 23
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: week 0
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: week 12
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: week 23
Other measures of clinical, psychological, and functional outcome
Time frame: week 0
Other measures of clinical, psychological, and functional outcome
Time frame: week 12
Other measures of clinical, psychological, and functional outcome
Time frame: week 23
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Rachel Yehuda, PhD principal investigator
James J Peters VAMC/Mount Sinai School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone augmented Prolonged Exposure Therapy in people with Post Traumatic Stress Disorder, run by Bronx VA Medical Center 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Nov 2013. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Yehuda, PhD (718-741-4000 ext. 6964, rachel.yehuda@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2013.