NCT06759558RecruitingPhase 2
Allopregnanolone (Zuranolone) in Post-stroke Depression
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- 30 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Duke University
- Diseases
- Stroke
- NCT number
- NCT06759558
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 6
- From 30 Jan 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have abused or been dependent on narcotics, recreational drug use, or alcohol
- Antidepressant medications titration or initiation within 12 weeks of recruitment
Other illness
- History of attempted suicide
- History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke
Other
- Advanced liver or kidney problems
- Pregnant or plan to become pregnant
- Post-partum period or breastfeeding
- Active psychosis or suicidal ideation necessitating clinical intervention
Who the study is looking for
- 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)
Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke South Neurology Clinic 1L Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.