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RecruitingPhase 2

Allopregnanolone (Zuranolone) in Post-stroke Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 days
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether zuranolone is safe, is easy to tolerate, and helps treat moderate to severe depression after a stroke. It is for stroke survivors ages 21–65. Six people will take 50 mg by mouth for 14 days and give blood samples, answer questions about mood, and take a thinking and memory test.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 21–65, of any sex, race, or ethnic background.
  • Had a stroke caused by a blocked blood vessel or bleeding within 1 year before joining, confirmed by a CT or MRI scan.
  • Have moderate to severe depression after the stroke, with symptoms for at least 2 weeks and a score of 17 or higher on the Hamilton Depression Rating Scale.

Who can't join

  • Have abused or been dependent on narcotics, recreational drugs, or alcohol.
  • Have advanced liver or kidney problems.
  • Are pregnant or plan to become pregnant.
  • Have recently given birth or are breastfeeding.
  • Have ever attempted suicide.
  • Have active psychosis (trouble knowing what is real) or thoughts of suicide that need medical care.
  • Started an antidepressant or had its dose adjusted within 12 weeks before recruitment.
  • Had bipolar disorder, schizophrenia, or depression that did not respond to treatment before the stroke.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC