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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zuranolone | Experimental | Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zuranolone | Drug | Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone | 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. | 90 days |
| Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) | 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. | 90 Days |
| Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS) | 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. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90 | A mixed-effects model for repeated measures will be used for the secondary exploratory outcome and will include change from baseline in HAM-D at each visit as the dependent variable. Logistic regression models for repeated measures using the generalized estimating equation method will be applied for analysis of HAM-D response and HAM-D remission. HAM-D score ranges from 0-50. In general the higher the total score the more severe the depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheila Joshi | Contact | 919-684-1992 | DepressionAfterStroke@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nada El Husseini, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke South Neurology Clinic 1L | Recruiting | Durham | North Carolina | 27710-0400 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38292895 | Background | Wang S, Zhang W, Liu Z, Zhang T, Wang Y, Li W. Efficacy and safety of zuranolone in the treatment of major depressive disorder: a meta-analysis. Front Neurosci. 2024 Jan 16;17:1332329. doi: 10.3389/fnins.2023.1332329. eCollection 2023. | |
| 37132201 | Background | Clayton AH, Lasser R, Parikh SV, Iosifescu DV, Jung J, Kotecha M, Forrestal F, Jonas J, Kanes SJ, Doherty J. Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial. Am J Psychiatry. 2023 Sep 1;180(9):676-684. doi: 10.1176/appi.ajp.20220459. Epub 2023 May 3. |
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Data will be shared via publications and/or presentations
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000634505 | zuranolone |
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| Baseline, 15 days, 90 days |
| Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90 | The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety. | Baseline, 15 days, 90 days |
| Number of participants with HAM-D response at 3, 15, and 90 days | The HAM-D total score ranges from 0 to 54, with higher scores indicating greater severity of depression. Response is defined as having a > or = 50% score reduction. | 3 days, 15 days, 90 days |
| Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days | The HAM-D total score ranges from 0 to 54, with higher scores indicating greater severity of depression. Remission is defined as having a score < or = 7. | 3 days, 15 days, 90 days |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |