Stress Disorders, Post-TraumaticNCT00560781
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
A study of Stress Disorders, Post-Traumatic, run by Durham VA Medical Center at 1 site in United States.
Trial summary
This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to May 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age, any ethnic group, either sex
- DSM-IV diagnosis of PTSD by MINI (see schedule of events)
- No change in SSRI medications for > 4 weeks.
- No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
- Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Who cannot join
- Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
- Use of oral contraceptives or other hormonal supplementation such as estrogen.
- Significant suicidal or homicidal ideation.
- Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
- Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months
- Female patients who are pregnant or breast-feeding.
- Known allergy to study medication.
- Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the FDA; patients taking these agents will not be eligible for this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.
Read the detailed description
See brief summary
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Pregnenolone or Placebo
- Keywords
- PTSD, Pregnenolone, Cognition
- 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.
Pregnenolone or PlaceboDrug
Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pregnenolone Receives: Drug: Pregnenolone or Placebo |
| 2 | Placebo comparator | Placebo Receives: Drug: Pregnenolone or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS, BAC-A
Measured: Prospective
Secondary outcomes (1)
PCL, CD-RISC, CGI, BDI-II
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durham VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christine E Marx, MD MA, Principal investigator, Durham VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560781
- Sponsor's protocol ID
- VA IRB# 01023
- Status last verified
- Feb 2014
- First submitted
- 19 Nov 2007
- Last updated
- 26 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
- ClinicalTrials.gov ID
- NCT00560781
- Acronym / sponsor ID
- VA IRB# 01023
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Pregnenolone, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Durham VA Medical CenterUS federal agency
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 20 Nov 2007 (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 test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.
Detailed description
See brief summary
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 |
|---|---|---|
| 1 | Active comparator | Drug: Pregnenolone or PlaceboPregnenolone |
| 2 | Placebo comparator | Drug: Pregnenolone or PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years of age, any ethnic group, either sex
- DSM-IV diagnosis of PTSD by MINI (see schedule of events)
- No change in SSRI medications for > 4 weeks.
- No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
- Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Key exclusion criteria (8 listed)
- Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
- Use of oral contraceptives or other hormonal supplementation such as estrogen.
- Significant suicidal or homicidal ideation.
- Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
- Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months
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 |
|---|---|---|
| Pregnenolone or PlaceboPregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID | Drug | 1, 2 |
Primary outcome
CAPS, BAC-A
Time frame: Prospective
1 secondary outcome
PCL, CD-RISC, CGI, BDI-II
Time frame: Prospective
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 26 Feb 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.
Christine E Marx, MD MA principal investigator
Durham VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress Disorders, Post-Traumatic, run by Durham 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 8 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 26 Feb 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.
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.
What does the primary outcome measure?
CAPS, BAC-A (time frame: Prospective). 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 26 Feb 2014.