Actively Recruiting
Allopregnanolone (Zuranolone) in Post-stroke Depression
Led by Duke University · Updated on 2026-01-20
6
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Allopregnanolone (Zuranolone) in Post-stroke Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 65 years, any sex and race/ethnicity
- Clinical ischemic or hemorrhagic acute stroke confirmed by CT or MRI within 1 year prior to enrollment
- Moderate to severe post-stroke depression lasting at least 2 weeks with a Hamilton Depression Rating Scale score of 17 or higher
You will not qualify if you...
- History of narcotic, recreational drug, or alcohol abuse or dependence
- Advanced liver or kidney disease
- Pregnant, planning pregnancy, postpartum, or breastfeeding
- History of attempted suicide
- Active psychosis or suicidal thoughts requiring clinical intervention
- Started or changed antidepressant medications within 12 weeks before recruitment
- History of bipolar disorder, schizophrenia, or treatment-resistant depression before the stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke South Neurology Clinic 1L
Durham, North Carolina, United States, 27710-0400
Actively Recruiting
Research Team
S
Sheila Joshi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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