CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Pregnenolone 500 mg +2 moredrug
Likely dose
Pregnenolone 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03645096
NCT03645096Phase 1Completed
CompareCT.gov

NCCIH Development of Pregnenolone as a Treatment for Depression R61 Phase

University of Texas Southwestern Medical Center·interventional·Posted Aug 24, 2018·Updated May 1, 2024

In Brief

A Phase 1 clinical trial evaluating Pregnenolone 500 mg, Pregnenolone 800 mg, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 24, 2018
Enrollment StartSep 1, 2019
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.9 years ago

Interventions

Pregnenolone 500 mgdrug

Pregnenolone 500 mg capsule.

Pregnenolone 800 mgdrug

Pregnenolone 800 mg capsule.

Placebodrug

Placebo capsule manufactured to mimic pregnenolone capsule.