U.S. Army Medical Research and Development Command
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV) for at least 6 months
Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results
Negative urine drug screen for drugs of abuse
Negative urine pregnancy test for females of childbearing potential
Sexually active participants are required to use a medically acceptable form of birth control
You may not be if
Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI)
Females who are pregnant or currently breast feeding
Current or past psychotic disorder, bipolar Type I disorder, or dementia
Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
Participants unwilling to comply with the required alcohol prohibition during the trial
Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years
Participants with pending litigation related to the traumatic event
Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
Participants receiving psychotherapy without a stable paradigm for at least 3 months
Non-English speaking participants.
Clareo Health | Ganaxolone in Posttraumatic Stress Disorder (PTSD)
