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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called zuranolone, a pill designed to help people with depression after a stroke. The researchers aim to determine if zuranolone is safe and effective in improving depression symptoms in these patients. Participants will take the medication daily for 14 days, provide blood samples, and answer questions about their mood. The trial seeks individuals who have experienced a stroke in the past year and have dealt with moderate to severe depression for at least two weeks. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in depression treatment.

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.

Is there any evidence suggesting that zuranolone is likely to be safe for humans?

Research shows that zuranolone is generally easy for people to handle. In studies with patients who have major depressive disorder, many found the treatment straightforward and convenient, with no major safety issues. Some participants experienced side effects, but these were usually mild and short-lived. Early results suggest that zuranolone might also effectively reduce depression symptoms.

Since this trial is in Phase 2, researchers are still gathering information to confirm zuranolone's safety for people with post-stroke depression. However, its use in other types of depression offers some initial reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike current treatments for post-stroke depression, which often include selective serotonin reuptake inhibitors (SSRIs) like sertraline or escitalopram, Zuranolone acts on the brain's GABA receptors. This unique mechanism of action may help stabilize mood more rapidly. Researchers are particularly excited because Zuranolone could potentially provide relief within just 14 days, offering a faster response compared to traditional antidepressants that typically take several weeks to show effects.

What evidence suggests that zuranolone might be an effective treatment for post-stroke depression?

Research has shown that zuranolone, which participants in this trial will receive, may help treat depression. In studies involving individuals with major depressive disorder, zuranolone reduced depression symptoms. This medication alters brain chemicals related to mood. Early results suggest it might also aid in treating depression after a stroke, but further research is necessary. Overall, zuranolone has demonstrated potential to improve mood and reduce depression symptoms in similar conditions. ^{1 2 3 4 5}

Who Is on the Research Team?

Nada El Husseini, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10824890/

Efficacy and safety of zuranolone in the treatment of major ... Our findings suggest that zuranolone is a promising, simple, and convenient treatment for patients with major depressive disorder.

2. trial.medpath.com trial.medpath.com/clinical-trial/58bd127a43ed0fb5/nct06759558-allopregnanolone-post-stroke-depression

Allopregnanolone (Zuranolone) in Post-stroke Depression 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.

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1334694/full

Efficacy and tolerability of zuranolone in patients with ... The primary outcome was the change on day 15 depression severity scores compared to baseline. Secondary outcomes included remission and response rates on day 15 ...

4. trialx.com trialx.com/clinical-trials/listings/325210/allopregnanolone-zuranolone-in-post-stroke-depression/

Allopregnanolone (Zuranolone) in Post-stroke Depression 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 ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD014624.pub2/full

Brexanolone, zuranolone and related neurosteroid GABA ... The oral medication, zuranolone, probably helps more women by reducing their depression symptoms (response and remission) than placebo.