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Allopregnanolone (Zuranolone) in Post-stroke Depression

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
North Carolina
Duke South Neurology Clinic 1L
RECRUITING
Durham
Contact Information
Primary
Sheila Joshi
DepressionAfterStroke@duke.edu
919-684-1992
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 6
Treatments
Experimental: Zuranolone
Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov

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