NCT03645096

Who might be able to join this trial:

• You are a woman between the ages of 18 and 65 years old
• You have been diagnosed with mild or moderate major depression (MDD) based on a structured clinical interview
• You have not taken any psychiatric medications (except occasional sleep aids as needed) for at least 28 days before joining the study
• If you use sleep aids as needed, you have not taken them within 3 days before receiving the study drug, and you do not take them while on the study drug

Who may not be able to join:

• You have been diagnosed with severe major depression, or your depression symptom score is very high on a standard rating scale
• You are considered at high risk for suicide, including having an active plan or intent, more than 2 suicide attempts in your lifetime, or any attempt in the past 6 months
• Your depression has not responded to two or more adequate antidepressant treatments, or to electroconvulsive therapy (ECT), during your current episode
• You are pregnant, breastfeeding, have a severe thinking or intellectual disability, or are currently incarcerated
• You have a history of heart disease, irregular heart rhythm (atrial fibrillation), stroke, blood clots, or any serious or unstable medical condition
• You have previously had an allergic reaction or bad side effects from taking pregnenolone
• You currently have a substance use disorder, have used substances in the past 3 months, or test positive on a drug screen at the start of the study
• You are currently experiencing symptoms such as hallucinations, delusions, or disorganized thinking, or you have an eating disorder
• You have an anxiety disorder (such as severe OCD or PTSD) that is the main focus of your mental health treatment
• You have or have had hormone-sensitive conditions such as breast cancer, uterine or ovarian cancer, endometriosis, or uterine fibroids
• You have significant abnormal results on lab tests, a physical exam, or a heart tracing (ECG) (confirm with trial site)
• You are currently taking birth control pills that contain progestin (non-hormonal barrier methods are allowed)

Important: Always verify eligibility with the trial site directly before applying.