Development of Pregnenolone as a Treatment for Depression

Exclusion Criteria

• •Severe MDD based on DSM-5 severity criteria and/or a baseline HRSD score \> 27 (consistent with severe depressive symptom severity).
• •High risk for suicide (active SI with plan/intent or \> 2 lifetime attempts in lifetime or any in the past 6 months).
• •Treatment resistant depression (fail two adequate antidepressant trials or ECT during current episode).
• •Vulnerable populations (e.g. pregnant/nursing, severe cognitive or intellectual impairment, incarcerated).
• •Coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis, pulmonary embolism or blood clotting disorder, or any severe, life threatening or unstable, medical condition.
• •History of allergic reaction or side effects with prior pregnenolone use.
• •Current substance use disorder defined as meeting criteria for a use disorder based on the SCID interview and self-reported use within the past 3 months, or a positive baseline urine drug screen.
• •Current psychotic features (hallucinations, delusions, disorganized thought processes) or eating disorders.
• •Anxiety disorders of sufficient severity to be the primary focus of clinical attention (e.g. severe obsessive compulsive or post-traumatic stress disorders).
• •Hormone-sensitive conditions (i.e. breast cancer; uterine/ovarian cancer, endometriosis, uterine fibroids).
• •Clinically significant laboratory, physical examination, or electrocardiogram (ECG) findings.
• •Currently using oral contraceptives containing progestin (barrier methods allowed).