A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

September 1, 2018

Primary Completion Date

December 3, 2024

Study Completion Date

December 3, 2024

Conditions
Major Depressive DisorderMenopausePerimenopause
Interventions
DRUG

Pregnenolone

In a sequential parallel comparison design, in a double blind placebo controlled study, the efficacy of pregnenlone treatment relative to placebo in improving depression and anxiety symptoms, cognition, sleep, quality of life and vasomotor symptoms in preimenopausal and menopausal women with MDD.

DRUG

Placebo

In a sequential parallel comparison design, in a double blind placebo controlled study, the efficacy of pregnenlone treatment relative to placebo in improving depression and anxiety symptoms, cognition, sleep, quality of life and vasomotor symptoms in preimenopausal and menopausal women with MDD.

Trial Locations (1)

75390

UT Southwestern Medical Center, Dallas

All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

lead

University of Texas Southwestern Medical Center

OTHER

NCT03505905 - A Neurosteroid Intervention for Menopausal and Perimenopausal Depression | Biotech Hunter | Biotech Hunter