Neurosteroids for PTSD in Veterans (NCT03799562) | Clinical Trial Compass
CompletedPhase 2
Neurosteroids for PTSD in Veterans
United States96 participantsStarted 2019-05-01
Plain-language 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. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short "check-in" phone calls.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Change in Clinician Administered PTSD Scale for DSM-5 (Visit 6-Baseline)
Timeframe: Through study completion, an average of 5 years