Posttraumatic Stress DisorderPhase 2NCT00833339
Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
A Phase 2 study testing mifepristone in people with Posttraumatic Stress Disorder, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- mifepristone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Oct 2015
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male U.S. veteran
- Subject was exposed to combat or another criterion A traumatic event during military service
- Subject meets diagnostic criteria for chronic PTSD
Who cannot join
- Veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening
- Veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning
- Veteran has diabetes mellitus, an endocrinopathy, or another major medical illness.
- Veteran is taking oral corticosteroids
- Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- Veteran is currently suicidal or otherwise is in need of urgent clinical care
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- Veteran is currently receiving specialized trauma-focused psychotherapy (i.e., prolonged exposure, cognitive processing therapy or eye movement and desensitization reprocessing).
- Veteran is not willing to use effective means of birth control during the study or for 90 days after taking study medication
- Veteran has history of allergic reaction to mifepristone
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Julia A. Golier, M.D.
About this study
Official title: Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- mifepristone, placebo
- 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.
mifepristoneDrug
600 mg/day x 1 week
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | mifepristone Receives: Drug: mifepristone |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
Measured: baseline, endpoint, 4 week follow-up
Secondary outcomes (1)
Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.
Measured: baseline, endpoint, 4 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Julia A Golier, MD, Principal investigator, JJP VAMC; Mount Sinai Sch of Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833339
- Sponsor's protocol ID
- 3293-08-015
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2009
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
- ClinicalTrials.gov ID
- NCT00833339
- Acronym / sponsor ID
- 3293-08-015
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- May 2008
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 2 Feb 2009 (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 investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mifepristonemifepristone |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is a male U.S. veteran
- Subject was exposed to combat or another criterion A traumatic event during military service
- Subject meets diagnostic criteria for chronic PTSD
Key exclusion criteria (9 listed)
- Veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening
- Veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning
- Veteran has diabetes mellitus, an endocrinopathy, or another major medical illness.
- Veteran is taking oral corticosteroids
- Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
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 |
|---|---|---|
| mifepristone600 mg/day x 1 week | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
Time frame: baseline, endpoint, 4 week follow-up
1 secondary outcome
Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.
Time frame: baseline, endpoint, 4 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Julia A Golier, MD principal investigator
JJP VAMC; Mount Sinai Sch of Med
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mifepristone in people with Posttraumatic Stress Disorder, run by James J. Peters Veterans Affairs 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 3 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 1 Apr 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Julia A. Golier, M.D. (718-584-9000 ext. 5196, julia.golier@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status. (time frame: baseline, endpoint, 4 week follow-up). 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 1 Apr 2015.