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NCT03645096 · ClinicalTrials.gov registry record · Phase 1
Development of Pregnenolone as a Treatment for Depression
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT03645096: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT03645096 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03645096, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study 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.
Primary Outcome
Determine if an increase in Amygdala-PCC functional connectivity is observed with pregnenolone as compared to placebo. Amygdala-PCC functional connectivity was measured using resting state fMRI blood-oxygen-level dependent (BOLD) response and transformed to standardized z-scores (with μ=0 and σ=1) for analysis. Functional connectivity was measured three times corresponding to three treatments (500 mg pregnenolone, 800 mg pregnenolone, and placebo). Better outcomes are represented by greater fun
Interventions
- DRUG Placebo
- DRUG Pregnenolone 500 mg
- DRUG Pregnenolone 800 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 1 |
What the finished NCT03645096 record still lists
NCT03645096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03645096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03645096 about?
NCT03645096 is a clinical study titled "Development of Pregnenolone as a Treatment for Depression". 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...
What is the current status of trial NCT03645096?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-09-01. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT03645096?
The interventions under investigation include: Placebo (DRUG), Pregnenolone 500 mg (DRUG), Pregnenolone 800 mg (DRUG).
Who is sponsoring clinical trial NCT03645096?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03645096's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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