Status:
COMPLETED
Neurosteroids for PTSD in Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration is 10 weeks. Elig...
Detailed Description
BACKGROUND: There is an acute and urgent need to develop new and effective posttraumatic stress disorder (PTSD) pharmacotherapies, as there are currently only two FDA-approved medications for the trea...
Eligibility Criteria
Inclusion
- DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3
- Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential
- Birth control methods must be non-hormonal
- No anticipated need to alter psychiatric medications for duration of study involvement
- Ability to participate fully in the informed consent process
Exclusion
- History of allergy to pregnenolone
- Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms
- Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern
- Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted
- Serious unstable medical illness, such as:
- history of cerebrovascular accident
- prostate
- uterine or breast cancer
- others (at the discretion of the PI and medical oversight team)
- Medical conditions not well controlled will be excluded, at the discretion of the PI and Medical Team
- Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to:
- antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone
- mood stabilizers such as carbamazepine, divalproex, lamotrigine, topiramate
- atypical antipsychotics, and other agents including prazosin
- However, there may be no changes in psychotropic medications for PTSD 4 weeks prior to study randomization
- Benzodiazepine use
- Current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than mild TBI (assessed at screening)
- Initiation or change in psychotherapy within 3 months of randomization
- i.e., psychotherapy must be stable for 3 months prior to study start
- Participants on hormonal therapies such as finasteride or hormonal birth control
- Female participants who are pregnant or breast-feeding
- As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry
- Mild Alcohol Use Disorder is not exclusionary, at the judgment of the PI and her medical team
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03799562
Start Date
May 1 2019
End Date
July 14 2025
Last Update
July 16 2025
Active Locations (1)
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1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875