Neurosteroids in PTSD - Biomarkers to Therapeutics

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, DHEA Read More

Inclusion Criteria:

• OEF/OIF/OND era Veterans
• PTSD diagnosis (CAPS-5 score 33).

• Negative pregnancy test if female.

  • Sexually active subjects are required to use a medically acceptable form of birth control if they are of childbearing potential and could become pregnant during the study.
  • A medically acceptable form of birth control includes non-hormonal intrauterine devices, surgical sterilization, or double barrier methods (e.g., diaphragm with contraceptive jelly, condom with contraceptive foam, cervical caps with contraceptive jelly).
  • Sexual abstinence with agreement to continue abstinence or to use a medically acceptable method of contraception should sexual activity occur is permissible.
• Female participants must have had a normal mammogram within the last year (if older than 40)
• Female participants must have had a normal pelvic exam within the last year
• No change in medications less than 4 weeks before baseline assessment
• No anticipated need to alter medications for PTSD for the 6-week study duration (as determined by study physician's review of records and/or discussion with prescribing physician).
• Ability to fully participate in the informed consent process

Exclusion Criteria:

• Unstable medical or neurological illness, including seizures, renal impairment or CVA and inability to participate in neuroimaging (fMRI).
• Use of oral contraceptives or other hormonal supplements, as it is unclear if DHEA metabolism to other neurosteroids such as estradiol may potentially impact contraceptive efficacy.
• Significant suicidal or homicidal ideation.
• Current DSM-5 diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder (including major depression with psychotic features), or cognitive disorder due to a general medical condition.
• Female patients who are pregnant or breast-feeding.
• Known allergy to study medication.
• History of moderate or severe TBI.
• Substance dependence within past three months, per DSM-5 criteria (excluding caffeine and nicotine).
• Abnormal prostate specific antigen (PSA; >2.5ng/ml in males age 49 or less; >4ng/ml in males age 50 or greater) or history of prostate cancer, breast cancer, or uterine cancer.
• A family history of prostate, breast or endometrial cancer in a first-degree relative.
• Presence of any factors/conditions, medical or non-medical, that may interfere with conduction of study assessments in the judgment of the study team.
• Serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions or behaviors that would compromise participation and/or likely to lead to worsening of symptoms during the course of the study in the opinion of study physician and research team.
• Are non-ambulatory or require the use of crutches or a walker.
• Taking Narcotic medications or benzodiazepines for any reason.