Recruiting

Allopregnanolone (Zuranolone) in Post-stroke Depression

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ClinicalTrials.gov IDNCT06759558

PhasePHASE2

Enrollment6

SponsorDuke University

Age21 Years – 65 Years

SexALL

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Conditions studied

Post Stroke Depression

About this study

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.

Interventions

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

Primary outcomes

Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone (90 days)
Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) (90 Days)
Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS) (90 Days)

Eligibility information

Inclusion Criteria: * 21-65 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 Criteria: * 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

Study locations

Duke South Neurology Clinic 1L, Durham, North Carolina 27710-0400 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-10.