Zuranolone for Depression Following a Stroke

(ALLO in PSD Trial)

Overseen By Sheila Joshi

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Antidepressants

Disqualifiers: Substance abuse, Liver problems, Pregnancy, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 2 weeks

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have started or changed antidepressant medications within 12 weeks before joining. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug zuranolone for depression following a stroke?

Research shows that zuranolone, a drug used for major depressive disorder (MDD) and postpartum depression (PPD), can quickly reduce symptoms of depression. In studies, patients taking zuranolone experienced significant improvements in their depression scores compared to those taking a placebo, suggesting it may help with depression after a stroke as well. ^{1 2 3 4 5}

How is the drug zuranolone unique for treating depression after a stroke?

Zuranolone is unique because it is an oral neuroactive steroid that works by enhancing the activity of GABAA receptors in the brain, which can lead to faster relief of depressive symptoms compared to traditional antidepressants. It is also notable for its short, 14-day treatment course, which is different from the longer durations typically required for other antidepressant medications. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Nada El Husseini, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for stroke survivors who are dealing with moderate to severe depression after their stroke. Only six people will be enrolled, and they must take a synthetic hormone called zuranolone orally for two weeks while also providing blood samples and completing mood and cognitive assessments.

Inclusion Criteria

I am between 21 and 65 years old.

I have been feeling very down for at least 2 weeks after my stroke.

I had a stroke confirmed by a scan within the last year.

Exclusion Criteria

History of abusing or being dependent on narcotics, recreational drug use, or alcohol

I haven't started or changed my antidepressant dose in the last 3 months.

I do not have severe mental health issues needing urgent care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 50 mg of zuranolone once daily for 14 days

2 weeks

Daily visits for medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 15 and 90 days

12 weeks

Assessments at 15 days and 90 days

Treatment Details

Interventions

• Zuranolone

Trial Overview The study is testing the safety and tolerance of zuranolone in treating post-stroke depression. All participants will receive 50 mg of this oral medication daily for 14 days to see if it helps improve symptoms of depression.

Participant Groups

Group I: Zuranolone Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Nada El Husseini, MD, MHS

Lead Sponsor

Trials

1

Recruited

6+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of zuranolone in major depressive disorder: a meta-analysis of factor effect and dose-response analyses. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double-blind, randomized, placebo-controlled, phase 2 clinical trial. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of zuranolone for the treatment of depression: A systematic review and meta-analysis. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Zuranolone: First Approval. [2023]