What side effects are associated with this type of intervention?

Common treatments for postpartum psychosis include antipsychotics, mood stabilizers, and in some cases, electroconvulsive therapy (ECT). For treatments similar to Zulresso (brexanolone), which modulates GABA-A receptors, side effects can include sedation, dizziness, headache, and somnolence. Brexanolone specifically has been associated with risks of excessive sedation and sudden loss of consciousness, necessitating careful monitoring during administration. Other GABA-A receptor modulators may have similar side effects, emphasizing the need for close supervision during treatment.

What prior FDA approvals exist?

Zulresso (brexanolone) is the first FDA-approved treatment specifically for postpartum depression, which can include severe cases such as postpartum psychosis. Brexanolone works as a positive allosteric modulator of GABA-A receptors, enhancing the inhibitory effects of GABA in the brain. Prior to Zulresso, there were no FDA-approved medications specifically for postpartum psychosis; treatment typically involved off-label use of antipsychotics, mood stabilizers, and antidepressants. Zulresso represents a significant advancement in targeted therapy for postpartum mood disorders.

What other types of research exist?

As of 2024, promising novel alternatives to Zulresso (brexanolone) for postpartum psychosis may include other GABA-A receptor modulators or treatments that have shown efficacy in related conditions. One potential alternative is SAGE-217 (zuranolone), another GABA-A receptor modulator currently being investigated for various mood disorders, including postpartum depression. Additionally, esketamine, an NMDA receptor antagonist, has shown promise in treatment-resistant depression and may be considered for postpartum psychosis. It is essential to consult with a healthcare provider to determine the most appropriate treatment based on individual patient needs and the latest clinical evidence.

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GABA receptor modulator

Zulresso for Postpartum Psychosis

Q: What is the mechanism of action of this treatment?

Zulresso (brexanolone) is a positive allosteric modulator of GABA-A receptors, which enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain. This modulation helps to stabilize neural activity and reduce symptoms of severe mood disorders, such as Postpartum Psychosis. This mechanism is crucial for Postpartum Psychosis patients as it directly addresses the dysregulation of neural circuits that contribute to the severe mood disturbances and psychotic symptoms experienced during this condition. Effective modulation of GABA-A receptors can lead to rapid and significant improvements in mood and psychotic symptoms, providing much-needed relief for affected individuals.

Phase < 1

Waitlist Available

Led By Samantha Meltzer-Brody, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinician diagnosis of affective psychosis or mania

Age 18-45 years old

Must not have

Untreated or inadequately treated hypothyroidism or hyperthyroidism

Subject is in hepatic failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-treatment day 7

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests if Zulresso can help women with postpartum psychosis by improving their mood.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, similar medications can cause dizziness, headache, sleepiness or fatigue. There may also be risks associated with infusion reactions since Zulresso is administered intravenously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 45 years old.

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I gave birth within the last 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My thyroid condition is not well-managed.

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My liver is not working properly.

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My kidneys are failing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-treatment day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-treatment day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-treatment day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Positive and Negative Syndrome Scale (PANSS) score

Change in Young Mania Rating Scale (YMRS) score

Secondary study objectives

Change in Clinical Global Impression Scale (CGI)

Change in Edinburgh Postnatal Depression Scale (EPDS)

Change in Hamilton Rating Scale for Depression (HAM-D)

Side effects data

From 2021 Phase 3 trial • 28 Patients • NCT03665038

25%

Infusion site pain

13%

Sedation

13%

Nausea

13%

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Phase: Placebo

Double-Blind Phase: Brexanolone

Open-Label Phase: Brexanolone

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brexanolone

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Zulresso (brexanolone) is a positive allosteric modulator of GABA-A receptors, which enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain. This modulation helps to stabilize neural activity and reduce symptoms of severe mood disorders, such as Postpartum Psychosis. This mechanism is crucial for Postpartum Psychosis patients as it directly addresses the dysregulation of neural circuits that contribute to the severe mood disturbances and psychotic symptoms experienced during this condition. Effective modulation of GABA-A receptors can lead to rapid and significant improvements in mood and psychotic symptoms, providing much-needed relief for affected individuals.