Allopregnanolone (Zuranolone) in Post-stroke Depression (ALLO in PSD)

January 16, 2026 updated by: Duke University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710-0400
        • Recruiting
        • Duke South Neurology Clinic 1L
        • Principal Investigator:
          • Nada El Husseini, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone
Time Frame: 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.
90 days
Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
90 Days
Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS)
Time Frame: 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.
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days
Time Frame: 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.
3 days, 15 days, 90 days
Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90
Time Frame: 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.
Baseline, 15 days, 90 days
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90
Time Frame: Baseline, 15 days, 90 days
The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety.
Baseline, 15 days, 90 days
Number of participants with HAM-D response at 3, 15, and 90 days
Time Frame: 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.
3 days, 15 days, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Nada El Husseini, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

January 6, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00118406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared via publications and/or presentations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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