Zuranolone for Post-Stroke Depression
Allopregnanolone (Zuranolone) in Post-stroke Depression
Recruiting
Phase 2
Interventional Study
Post Stroke Depression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 6 (estimated)
- Sponsor
- Duke University · Other
Who this trial is looking for
This trial is looking for stroke survivors aged 21-65 who have moderate to severe depression after their stroke. Participants will take a medication called zuranolone for 14 days and complete some questionnaires.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 21 and 65 years old.
- I have had a stroke within the past year.
- I have been diagnosed with moderate to severe post-stroke depression.
- I have symptoms of depression that have lasted for at least 2 weeks.
- I score 17 or more on the Hamilton Depression Rating Scale.
You may not be able to join if
- I have abused or been dependent on drugs or alcohol.
- I have advanced liver or kidney problems.
- I am pregnant or planning to become pregnant.
- I am in the post-partum period or breastfeeding.
- I have a history of attempted suicide.
- I have active psychosis or suicidal thoughts requiring help.
- I have started or changed my antidepressant medication in the last 12 weeks.
- I have a history of bipolar disorder, schizophrenia, or treatment-resistant depression before my stroke.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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 pos…
Trial Locations
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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 w…
Contacts