Tests zuranolone for depression after a stroke
Tests whether zuranolone, a pill, is safe for stroke survivors with depression.
Plain-language title generated from the registry record
Registry title: Allopregnanolone (Zuranolone) in Post-stroke Depression
Key facts
- Where
- Durham, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 65 years old?
Source: NCT06759558, who can take part
Where in United States
- Duke South Neurology Clinic 1LDurham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT06759558
- Record updated
- 3 September 2026
- Original description
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:Read full original descriptionShow less
Allopregnanolone (Zuranolone) in Post-stroke Depression
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.
Inclusion: 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: Have abused or been dependent on narcotics, recreational drug use, or alcohol; Antidepressant medications titration or initiation within 12 weeks of recruitment; History of attempted suicide; History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke; Advanced liver or kidney problems; Pregnant or plan to become pregnant; Post-partum period or breastfeeding; Active psychosis or suicidal ideation necessitating clinical intervention.