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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.
Duke South Neurology Clinic 1L
Durham, North Carolina, United States
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 Days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 days, 15 days, 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.