---
title: Allopregnanolone (Zuranolone) in Post-stroke Depression
nct_id: NCT06759558
overall_status: RECRUITING
phase: PHASE2
sponsor: Duke University
study_type: INTERVENTIONAL
primary_condition: Post Stroke Depression
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06759558.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06759558"
ct_last_update_post_date: 2026-01-20
last_seen_at: "2026-05-12T07:31:23.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Allopregnanolone (Zuranolone) in Post-stroke Depression

**NCT ID:** [NCT06759558](https://clinicaltrials.gov/study/NCT06759558)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 6
- **Lead Sponsor:** Duke University
- **Collaborators:** American Heart Association
- **Conditions:** Post Stroke Depression
- **Start Date:** 2026-01-14
- **Completion Date:** 2026-06-30
- **CT.gov Last Update:** 2026-01-20

## Brief 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Zuranolone** (EXPERIMENTAL) — Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily.

## Interventions

- **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

- **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.
- **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.
- **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

- **Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90** _(time frame: Baseline, 15 days, 90 days)_
- **Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90** _(time frame: Baseline, 15 days, 90 days)_
- **Number of participants with HAM-D response at 3, 15, and 90 days** _(time frame: 3 days, 15 days, 90 days)_
- **Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days** _(time frame: 3 days, 15 days, 90 days)_

## Locations (1)

- Duke South Neurology Clinic 1L, Durham, North Carolina, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.duke south neurology clinic 1l|durham|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06759558.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06759558*  
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