RecruitingPhase 2NCT06759558

Allopregnanolone (Zuranolone) in Post-stroke Depression

Sponsor

Duke University

Enrollment

6 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Post-stroke Depression

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.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria3

years old of any sex and race/ethnicity
Clinical ischemic or hemorrhagic acute stroke (confirmed by CT or MRI) occurring within 1 year of date of enrollment
Moderate to severe PSD (Post-Stroke Depression) defined as having depressive symptoms lasting for at least 2 weeks and scoring 17 or more on the HAM-D (Hamilton Depression Rating Scale)

Exclusion Criteria8

Have abused or been dependent on narcotics, recreational drug use, or alcohol
Advanced liver or kidney problems
Pregnant or plan to become pregnant
Post-partum period or breastfeeding
History of attempted suicide
Active psychosis or suicidal ideation necessitating clinical intervention
Antidepressant medications titration or initiation within 12 weeks of recruitment
History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke