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RECRUITING
NCT06759558
PHASE2

Allopregnanolone (Zuranolone) in Post-stroke Depression

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are: * Is zuranolone safe to take by participants who have moderate to severe post-stroke depression? * Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression? * Does zuranolone treat moderate to severe post-stroke depression? The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days. Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-01-14

Completion Date

2026-06-30

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Zuranolone

Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.

Locations (1)

Duke South Neurology Clinic 1L

Durham, North Carolina, United States