NCT03645096

Development of Pregnenolone as a Treatment for Depression

NCCIH Development of Pregnenolone as a Treatment for Depression R61 Phase

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, 26 adult women meeting criteria for Major Depressive Disorder (MDD) as defined in DSM 5, will be randomized to a double-blind, placebo-controlled, crossover phase I clinical trial of pregnenolone (i.e. each participant receives 500 mg/d, 800 mg/d pregnenolone and placebo in random order). The study will consist of three 7-day treatment exposures to each pregnenolone dose with a 14-day washout between each exposure. Baseline evaluation will include medical and psychiatric history, psychiatric interview, standard laboratory analyses (i.e., blood draw, ECG), and a brief cognitive battery. Neuroimaging will be collected after each study drug or placebo administration. Study drug tolerability and participant safety will be assessed throughout the study (6 in-clinic visits + a safety visit) using structured clinical interviews, self-report questionnaires, and standard laboratory analyses.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Pregnenolone 500 mg	Pregnenolone 500 mg capsule.
DRUG	Pregnenolone 800 mg	Pregnenolone 800 mg capsule.
DRUG	Placebo	Placebo capsule manufactured to mimic pregnenolone capsule.

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2018-08-24
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study