Allopregnanolone (Zuranolone) in Post-stroke Depression
ConditionPost Stroke Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorDuke University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
Have abused or been dependent on narcotics, recreational drug use, or alcohol
Advanced liver or kidney problems
Pregnant or plan to become pregnant
Post-partum period or breastfeeding
Trial design
Treatments tested in this trial
- Zuranolone
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Duke University
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov