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New treatment option for Post Stroke Depression
Official title Allopregnanolone (Zuranolone) in Post-stroke Depression
ClinicalTrials.gov ID: NCT06759558
What this study is testing
What is Zuranolone?
Zuranolone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for post stroke depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.