Development of Pregnenolone as a Treatment for Depression R61

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

Pregnenolone, an over-the-counter supplement, is a naturally occurring neurosteroid made in the adrenal glands and brain. Preclinical research suggests pregnenolone has antidepressant, cognitive enhancing, and neuroprotective properties, particularly in women. The following hypothesis will be tested in this trial: pregnenolone is associated with improvement in depressive symptom severity in women that is associated with changes in the resting state functional connectivity (rsFC) and GABA.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• Women, ages 18-65 years, with current MDD (mild or moderate severity per DSM-5) based on SCID-CV.

• No psychotropic medications, other than PRN (as needed) hypnotics, within 28 days of randomization (medication free).

• PRN hypnotics allowed up to 3 days prior to study drug administrations but not while receiving study drug.

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).