Zuranolone (allopregnanolone) for post-stroke depression
Official title: Allopregnanolone (Zuranolone) in Post-stroke Depression
Run by Duke University · NCT06759558 · Data updated 2026-11-12
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 |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | January 30, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT06759558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Hyperbaric oxygen therapy for persistent post-stroke depression
This research will test whether hyperbaric oxygen therapy can reduce depressive symptoms in adults with long-standing post-stroke depression who are already on antidepressants.
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Predicting depression risk after an ischemic stroke
This project will try to use machine learning on clinical and other patient data to predict which people hospitalized with an acute ischemic stroke will develop depression.
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Building physical capacity after chronic stroke
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Effects of natural light on stroke recovery complications
This study tests if using natural light during rehab can help stroke patients feel less depressed and tired as they recover.
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Telephone/video behavioral activation to prevent depression after a first stroke in low-income older adults
This project will test whether coaching-style behavioral activation delivered by trained lay counselors over phone or video can prevent depression in low-income older adults who recently had a first stroke and currently have mild or no depressive symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.