Zuranolone (allopregnanolone) for post-stroke depression
Allopregnanolone (Zuranolone) in Post-stroke Depression
This trial will test whether a 14-day course of oral zuranolone is safe, well tolerated, and can reduce moderate to severe depression in adults 21–65 who developed depression within a year after a stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06759558 on ClinicalTrials.gov |
What this trial studies
This Phase II, open-label trial enrolls six adults with ischemic or hemorrhagic stroke within the past year who have moderate to severe post-stroke depression (HAM-D ≥17). All participants receive 50 mg of oral zuranolone once daily for 14 days with clinical and safety monitoring. Study procedures include blood draws, mood questionnaires, and a brief cognitive assessment to track tolerability and symptom change. The primary goals are to characterize safety and tolerability in this population and to look for early signs that depressive symptoms improve following treatment.
Who should consider this trial
Good fit: Adults aged 21–65 with a confirmed ischemic or hemorrhagic stroke within the past year and moderate to severe post-stroke depression (HAM-D score ≥17) who meet the study's other eligibility criteria are ideal candidates.
Not a fit: People with a history of bipolar disorder, schizophrenia, active psychosis or suicidal ideation requiring intervention, recent substance dependence, advanced liver or kidney disease, recent antidepressant initiation/titration, pregnancy or breastfeeding, or prior treatment-resistant depression before the stroke are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, zuranolone could provide a short, oral treatment that rapidly reduces depressive symptoms for some stroke survivors.
How similar studies have performed: Zuranolone has produced rapid antidepressant effects in larger trials for major depressive disorder and postpartum depression, but its use specifically for post-stroke depression is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke South Neurology Clinic 1L — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Nada El Husseini, MD — Duke University
- Study coordinator: Sheila Joshi
- Email: DepressionAfterStroke@duke.edu
- Phone: 919-684-1992
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.