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NCT Number: NCT06759558

Allopregnanolone (Zuranolone) in Post-stroke Depression

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.

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Key information

Conditions

Post Stroke Depression Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zuranolone

Drug

Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheila Joshi

CONTACT

[email protected]

919-684-1992

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • American Heart Association

Registry information

Acronym: ALLO in PSD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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