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Allopregnanolone (Zuranolone) in Post-stroke Depression

Study acronym: ALLO in PSD
StatusRecruiting
PhasePhase 2
Started2026-01-30
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-09-04
critical
Primary completion pushed: 2026-06-30 → 2027-06-30
2026-09-04
minor
Completion pushed: 2026-06-30 → 2027-06-30
Trial Details
NCT Number NCT06759558
Lead Sponsor Duke University
Collaborators: American Heart Association
Conditions Post Stroke Depression
Enrollment 6 participants
Start Date 2026-01-30
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-03