Anxiety & Depression Association of America

Allopregnanolone (Zuranolone) in Post-stroke Depression

Purpose

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.

Condition

Post Stroke Depression

Eligibility

Eligible Ages: Between 21 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Zuranolone	Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily.	Drug: Zuranolone Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Duke University

Study Contact

Sheila Joshi
919-684-1992
Sheila_Joshi@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.