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GABA receptor modulator

Zulresso for Postpartum Psychosis

Q: How many participants have been included in the research so far?

Affirmative. Utilizing clinicaltrials.gov as a source, it is evident that this medical trial commenced on February 23rd 2022 and was updated most recently on March 28th 2022. 10 test subjects are necessary for the study to be conducted at one site only.

Q: Does this experimental procedure have an age restriction, particularly for those over 30?

This trial stipulates that participants must fall within the age parameters of 18 and 45.

Q: For whom would this research be most beneficial?

The requirements for this clinical trial involve being between 18 and 45 years old as well as having a diagnosed psychotic disorder. Up to 10 people are eligible for participation in the study.

Q: Are there any vacancies remaining in this clinical experiment?

Affirmative, clinicaltrials.gov attests to the veracity of this medical study's active recruitment process that started on February 23rd 2022 and has been recently updated as of March 28th 2022. At present, 10 people are needed from a single centre for participation in the trial.

Phase < 1

Recruiting

Led By Mary Kimmel, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-treatment day 7

Awards & highlights

Study Summary

This trial will study whether the drug Zulresso is effective in treating postpartum psychosis, a severe form of postpartum depression.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am between 18 and 45 years old.

Select...

I gave birth within the last 12 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Positive and Negative Syndrome Scale (PANSS) score

Change in Young Mania Rating Scale (YMRS) score

Secondary outcome measures

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%

Nausea

13%

Upper respiratory tract infection

13%

Sedation

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Phase: Placebo

Double-Blind Phase: Brexanolone

Open-Label Phase: Brexanolone

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,604 Total Patients Enrolled

Sage TherapeuticsIndustry Sponsor

49 Previous Clinical Trials

11,751 Total Patients Enrolled

Mary Kimmel, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

Media Library

Brexanolone (GABA receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05314153 — Phase < 1

Postpartum Psychosis Research Study Groups: Open Label - Active Drug

Postpartum Psychosis Clinical Trial 2023: Brexanolone Highlights & Side Effects. Trial Name: NCT05314153 — Phase < 1

Brexanolone (GABA receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05314153 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been included in the research so far?

"Affirmative. Utilizing clinicaltrials.gov as a source, it is evident that this medical trial commenced on February 23rd 2022 and was updated most recently on March 28th 2022. 10 test subjects are necessary for the study to be conducted at one site only."

Answered by AI

Does this experimental procedure have an age restriction, particularly for those over 30?

"This trial stipulates that participants must fall within the age parameters of 18 and 45."

Answered by AI

For whom would this research be most beneficial?

"The requirements for this clinical trial involve being between 18 and 45 years old as well as having a diagnosed psychotic disorder. Up to 10 people are eligible for participation in the study."

Answered by AI

Are there any vacancies remaining in this clinical experiment?

"Affirmative, clinicaltrials.gov attests to the veracity of this medical study's active recruitment process that started on February 23rd 2022 and has been recently updated as of March 28th 2022. At present, 10 people are needed from a single centre for participation in the trial."

Answered by AI

Recent research and studies

The LancetJournal

Brexanolone Injection in Post-partum Depression: Two Multicentre, Double-blind, Randomised, Placebo-controlled, Phase 3 Trials

Meltzer-Brody, Samantha, Helen Colquhoun, Robert Riesenberg, C Neill Epperson, Kristina M Deligiannidis, David R Rubinow, Haihong Li, et al.. 2018. “Brexanolone Injection in Post-partum Depression: Two Multicentre, Double-blind, Randomised, Placebo-controlled, Phase 3 Trials”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(18)31551-4.

The LancetJournal

Brexanolone (SAGE-547 Injection) in Post-partum Depression: A Randomised Controlled Trial

Kanes, Stephen, Helen Colquhoun, Handan Gunduz-Bruce, Shane Raines, Ryan Arnold, Amy Schacterle, James Doherty, et al.. 2017. “Brexanolone (SAGE-547 Injection) in Post-partum Depression: A Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)31264-3.

Human Psychopharmacology: Clinical and ExperimentalJournal

Open-label, Proof-of-concept Study of Brexanolone in the Treatment of Severe Postpartum Depression

Kanes, Stephen J., Helen Colquhoun, James Doherty, Shane Raines, Ethan Hoffmann, David R. Rubinow, and Samantha Meltzer-Brody. 2017. “Open-label, Proof-of-concept Study of Brexanolone in the Treatment of Severe Postpartum Depression”. Human Psychopharmacology: Clinical and Experimental. Wiley. doi:10.1002/hup.2576.

DrugsJournal