Stress Disorders, Post-Traumatic
Conditions
Keywords
PTSD, Pregnenolone, Cognition
Brief 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.
Detailed description
See brief summary
Interventions
DRUGPregnenolone or Placebo
Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID
Sponsors
Durham VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years of age, any ethnic group, either sex 2. DSM-IV diagnosis of PTSD by MINI (see schedule of events) 3. No change in SSRI medications for \> 4 weeks. 4. No anticipated need to alter any psychotropic medications for the 10-week duration of the study. 5. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Exclusion criteria
1. Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer 2. Use of oral contraceptives or other hormonal supplementation such as estrogen. 3. Significant suicidal or homicidal ideation. 4. Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary. 5. 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 6. Female patients who are pregnant or breast-feeding. 7. Known allergy to study medication. 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAPS, BAC-A | Prospective |
Secondary
| Measure | Time frame |
|---|---|
| PCL, CD-RISC, CGI, BDI-II | Prospective |
Countries
United States
Outcome results
None listed