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NCT06759558 · ClinicalTrials.gov registry record · Phase 2
Allopregnanolone (Zuranolone) in Post-stroke Depression
A Phase 2 study of Post Stroke Depression, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06759558: Recruiting Phase 2 study of Post Stroke Depression, sponsored by Duke University.
NCT06759558 is a Phase 2 study of Post Stroke Depression that is actively recruiting participants, run by Duke University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06759558, a Phase 2 study of Post Stroke Depression, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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, h
Conditions Studied
Interventions
- DRUG Zuranolone
Study Locations (1)
North Carolina
- Duke South Neurology Clinic 1L - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2026-01-14 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What NCT06759558 shows while recruiting
NCT06759558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Post Stroke Depression appearing as the primary indexed condition, and to 1 intervention - of which Zuranolone is the first listed.
NCT06759558 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06759558 about?
NCT06759558 is a clinical study titled "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 w...
What is the current status of trial NCT06759558?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2026-01-14. Estimated completion is 2026-06-30.
What conditions does trial NCT06759558 study?
This clinical trial studies the following conditions: Post Stroke Depression.
What interventions are being tested in trial NCT06759558?
The interventions under investigation include: Zuranolone (DRUG).
Who is sponsoring clinical trial NCT06759558?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06759558 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Stroke Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06759558's enrollment target sits among peer trials
6 1997th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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