Allopregnanolone (Zuranolone) in Post-stroke Depression (ALLO in PSD)

Duke University

Status and phase: Enrolling; Phase 2

Conditions: Post Stroke Depression

Treatments: Drug: Zuranolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06759558

Pro00118406

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Zuranolone

Experimental group

Description:

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

Treatment:

Drug: Zuranolone