Zulresso for Postpartum Psychosis

Recruiting in Palo Alto (17 mi)

Overseen BySamantha Meltzer-Brody, MD, MPH

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Breakthrough Therapy

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial tests if Zulresso can help women with postpartum psychosis by improving their mood.

Eligibility Criteria

This trial is for adult women aged 18-45 who have given birth within the last year and are experiencing postpartum psychosis. They must be able to consent to treatment, not currently pregnant, and without severe kidney or liver issues, significant anemia, untreated thyroid problems, or a history of schizophrenia.

Inclusion Criteria

I have been diagnosed with affective psychosis or mania by a doctor.

I am between 18 and 45 years old.

I gave birth within the last 12 months.

Exclusion Criteria

My thyroid condition is not well-managed.

My liver is not working properly.

My kidneys are failing.

Participant Groups

The study tests Zulresso (brexanolone) on women with postpartum psychosis to see if it's as effective as it has been for postpartum depression. It's an open-label trial where all participants know they're receiving the actual medication.

1Treatment groups

Experimental Treatment

Group I: Open Label - Active DrugExperimental Treatment1 Intervention

Brexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone.

Brexanolone is already approved in United States for the following indications:

🇺🇸 Approved in United States as Zulresso for: