Allopregnanolone (Zuranolone) in Post-stroke Depression

Launched by DUKE UNIVERSITY · Dec 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called zuranolone, which is a synthetic version of a natural substance that may help with depression after a stroke. The main purpose of the trial is to find out if zuranolone is safe and if people with moderate to severe post-stroke depression can tolerate it well. Researchers also want to see if this medication can improve the symptoms of depression in stroke survivors. The trial will include six participants who will take zuranolone for 14 days and will be asked to provide blood samples and complete questionnaires about their mood and thinking.

To be eligible for this study, participants should be aged between 21 and 65 years, have had a stroke within the past year, and have been experiencing significant depressive symptoms for at least two weeks. However, individuals with a history of certain mental health conditions, substance abuse, or serious health issues like liver or kidney problems will not be included. It’s important to note that this trial is not yet recruiting participants, but it aims to help improve treatment options for those dealing with post-stroke depression.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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
• • History of attempted suicide
• • Active psychosis or suicidal ideation necessitating clinical intervention
• • Antidepressant medications titration or initiation within 12 weeks of recruitment
• • History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke