Neurosteroids for Treatment of PTSD in Veterans

Ki vehet részt

• At study outset: DSM-5 diagnosis of PTSD with CAPS-5 Total Score >=30. Following protocol amendment effective 4/13/2023: criterion modified to require diagnosis of PTSD using the CAPS-5 definition, defined by the following: at least one Criterion B symptom, at least one Criterion C symptom, at least 2 Criterion D symptoms and at least 2 Criterion E symptoms. This thus replaced the firm cutoff of CAPS-5 Total Score >=30
• 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

Ki nem vehet részt

• 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
• 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
• 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
• History of allergy to pregnenolone
• Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms
• 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
• 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)
• 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
• Benzodiazepine use
• Female participants who are pregnant or breast-feeding