Post-traumatic Stress DisorderPhase 2NCT00993629
Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
A Phase 2 study testing pregnenolone in people with Post-traumatic Stress Disorder and Major Depressive Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Major Depressive Disorder
- What is being tested?
- pregnenolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2010
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of PTSD,
- diagnosis of MDD,
- age 18-55,
- no change in psychotropic medication for >=4 weeks,
- no anticipated need to to alter psychotropic medication for duration of study
Who cannot join
- Unstable medical/neurological illness,
- diagnosis of bipolar disorder, schizophrenia or other psychotic disorder,
- cognitive disorder,
- substance dependence,
- positive urine drug screen at screening,
- use of hormonal supplementation,
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- pregnancy/lactation,
- female patients who are sexually active and not using acceptable non-hormonal birth control,
- initiation/change of psychotherapy within 3 months of randomization,
- recent/current electroconvulsive therapy,
- regular use of opiates/barbiturates/benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Durham
Durham, North Carolina, 27705
About this study
Official title: Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans
This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.
Read the detailed description
PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.
- Being tested
- pregnenolone, placebo
- Keywords
- PTSD, Depression, Neurosteroids
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnenoloneDrug
Administered adjunctively to "treatment as usual"
placeboDrug
adjunctive placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | adjunctive pregnenolone Receives: Drug: pregnenolone |
| Arm 2 | Placebo comparator | adjunctive placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: PI turned down funding.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Victoria M Payne, MD MS, Principal investigator, VA Medical Center, Durham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993629
- Sponsor's protocol ID
- B7064-W
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2009
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT00993629
- Acronym / sponsor ID
- B7064-W
- Keywords
- PTSD, Depression, Neurosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI turned down funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Oct 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.
This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.
Detailed description
PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: pregnenoloneadjunctive pregnenolone |
| Arm 2 | Placebo comparator | Drug: placeboadjunctive placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of PTSD,
- diagnosis of MDD,
- age 18-55,
- no change in psychotropic medication for >=4 weeks,
- no anticipated need to to alter psychotropic medication for duration of study
Key exclusion criteria (11 listed)
- Unstable medical/neurological illness,
- diagnosis of bipolar disorder, schizophrenia or other psychotic disorder,
- cognitive disorder,
- substance dependence,
- positive urine drug screen at screening,
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 |
|---|---|---|
| pregnenoloneAdministered adjunctively to "treatment as usual" | Drug | Arm 1 |
| placeboadjunctive placebo | Drug | Arm 2 |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
Victoria M Payne, MD MS principal investigator
VA Medical Center, Durham
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 pregnenolone in people with Post-traumatic Stress Disorder and Major Depressive Disorder, run by US Department of Veterans Affairs 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 11 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: withdrawn, as of the sponsor's last update on 27 Oct 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: 8 weeks). 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 27 Oct 2014.