Allopregnanolone (Zuranolone) in Post-stroke Depression

Conditions

• Post Stroke Depression

Eligibility Criteria

Sex

ALL

Age

21 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Zuranolone — DRUG
  Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.

Study Details

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.

Key Dates

Start date

Jan 14, 2026

Status verified

Jan 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

6 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Zuranolone
  Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily.

Primary Outcome Measure

Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone [ Time Frame: 90 days ]

Central Contacts

• Sheila Joshi
  919-684-1992
  [email protected]

Locations (1)

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