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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 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 34 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03645096
The ClinicalTrials.gov registry entry for NCT03645096 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03645096 reports 0 study locations.
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.
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