Recruiting
Phase 2

Zuranolone

Sponsor:

Duke University

Code:

NCT06759558

Conditions

Post Stroke Depression

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Zuranolone

Study Details

Brief 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.

Conditions

Post Stroke Depression

Study ID

NCT06759558

Start date

Jan 30, 2026

Status verified date

Jan, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zuranolone

Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily.

Interventions

Zuranolone

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sheila Joshi

919-684-1992DepressionAfterStroke@duke.edu

Locations

Duke South Neurology Clinic 1L

Recruiting

Durham, North Carolina, United States, 27710-0400

Contacts

Nada El Husseini, MD

919-970-2091nada.elhusseini@duke.edu

Sheila N Joshi, BA

9196841992sheila.joshi@duke.edu

Principal Investigator:

Nada El Husseini, MD

More Information

Sponsor

Duke University

Last update posted

Sep 3, 2026

Last verified

Jan, 2026

Keywords

  • zuranolone
  • post stroke depression
  • allopregnanolone
  • stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-03.