Clinical trial NCT06759558: Allopregnanolone (Zuranolone) in Post-stroke Depression
Official title: Allopregnanolone (Zuranolone) in Post-stroke Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Post Stroke Depression
Keywords: zuranolone
post stroke depression
allopregnanolone
stroke
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2025-01-06
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone
timeFrame: 90 days
measure: Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 90 Days
measure: Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS)
timeFrame: 90 Days
Secondary outcomes:
measure: Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90
timeFrame: Baseline, 15 days, 90 days
measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90
timeFrame: Baseline, 15 days, 90 days
measure: Number of participants with HAM-D response at 3, 15, and 90 days
timeFrame: 3 days, 15 days, 90 days
measure: Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days
timeFrame: 3 days, 15 days, 90 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke South Neurology Clinic 1L
state: North Carolina
Study officials:
affiliation: Duke University
name: Nada El Husseini, MD
role: PRINCIPAL_INVESTIGATOR
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