Allopregnanolone in Post-Stroke Depression

Phase 2

Not yet recruiting

• Conditions: Post Stroke Depression
• Interventions: Drug: Zuranolone

• Registration Number: NCT06759558
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Status Verified: 2025-01
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Study Start: 2025-04-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zuranolone	Zuranolone	Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone	90 days	TEAEs: suicidality and signs of abuse/dependence such as suicidal thinking and associated behaviors, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania, psychosis, worsening depression.; Other TEAEs include: dizziness, somnolence, significant drowsiness causing impairment of daily activity, skin rash, abdominal pain, diarrhea, urinary tract infection, fatigue, memory impairment, tremor, muscle twitching, myalgia, headache, hypoesthesia, recurrent stroke, hypertension, hypotension, falls, confusion.
Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)	90 Days	The C-SSRS will be used to evaluate the intensity of suicidal ideation. The score ranges from 2 to 25, where a higher score indicates greater ideation.
Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS)	90 Days	The ESS will be used to evaluate the intensity of somnolence. The score ranges from 0 to 24, where a score from 11-24 indicates excessive daytime sleepiness.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90	Baseline, 15 days, 90 days	A mixed-effects model for repeated measures will be used for the secondary exploratory outcome and will include change from baseline in HAM-D at each visit as the dependent variable. Logistic regression models for repeated measures using the generalized estimating equation method will be applied for analysis of HAM-D response and HAM-D remission.; HAM-D score ranges from 0-50. In general the higher the total score the more severe the depression.
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90	Baseline, 15 days, 90 days	The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety.
Number of participants with HAM-D response at 3, 15, and 90 days	3 days, 15 days, 90 days	The HAM-D total score ranges from 0 to 54, with higher scores indicating greater severity of depression. Response is defined as having a \> or = 50% score reduction.
Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days	3 days, 15 days, 90 days	The HAM-D total score ranges from 0 to 54, with higher scores indicating greater severity of depression. Remission is defined as having a score \< or = 7.

Trial Locations

Locations (1)

Duke South Neurology Clinic 1L; 🇺🇸 Durham, North Carolina, United States