Development of Pregnenolone as a Treatment for Depression
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.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2022-05-31
- Completion
- 2022-05-31
Outcome
Missed primary endpoint
registry analysis (superiority test); Pregnenolone (500 mg) vs Placebo; p = .195; NCT03645096 ↗
registry analysis (superiority test); Pregnenolone (500 mg) vs Placebo; p = .468; NCT03645096 ↗
registry analysis (superiority test); Pregnenolone (500 mg) vs Placebo; p = .316; NCT03645096 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregnenolone | Other / unclassified | 500 mg | Oral |
| Subject | Pregnenolone | Other / unclassified | 800 mg | Oral |