Effects Zulresso on Postpartum Psychosis

August 23, 2024 updated by: University of North Carolina, Chapel Hill

Open Label Study of the Efficacy, Safety and Tolerability of Zulresso in the Treatment of Adult Women With Postpartum Psychosis

This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. This study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single site, open label study design to evaluate the efficacy, safety and tolerability of Zulresso in female subjects diagnosed with postpartum psychosis.

Participants will be consented, and if possible, participation will be discussed with available family members. Participants will take a consent questionnaire prior to consenting to ensure the voluntary nature and understanding of study procedures. Participants will undergo a screening visit including diagnostic interviews, clinical laboratory assessments and an EKG to determine eligibility. If eligible, participants will be admitted in-patient to UNC Hospitals and administered a continuous 60-hour infusion of Zulresso using the approved FDA REMS protocol for postpartum depression. A target dose of 90 μg/kg/hour will be administered over a period of 2.5 days following a strict tapering schedule. Monitoring will occur for an additional 12 hours after the infusion. The subject will participate in 6 follow up visits at day 7 post-infusion, day 14, day 21, day 30, day 60 and day 90.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All participating subjects sign an informed consent form;
  • Age 18-45 years old;
  • Onset of affective psychosis or mania symptoms in the 3rd trimester, within 4 weeks of delivery, or within 4 weeks of weaning;
  • Clinician diagnosis of affective psychosis or mania;
  • ≤12 months postpartum at screening

Exclusion Criteria:

  • Positive pregnancy test at screening or day 1;
  • Recent pregnancy did not result in a live birth;
  • Subject is in renal failure;
  • Subject is in hepatic failure;
  • Subject is anemic (hemoglobin ≤10 g/dL);
  • Untreated or inadequately treated hypothyroidism or hyperthyroidism;
  • History of schizophrenia, and/or schizoaffective disorder;
  • Current/active alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label - Active Drug
Brexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone.
Drug: Brexanolone
Brexanolone injection is an Federal Drug Administration (FDA)-approved drug to treat postpartum depression. It is administered via continuous intravenous infusion over a 60-hour time period.
Other Names:
  • Zulresso

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Positive and Negative Syndrome Scale (PANSS) score
Time Frame: Baseline to post-treatment day 7
The PANSS is a standardized, clinical interview that rates the presence and severity of psychosis. The PANSS yields a total average symptom score, based on 30 items rated from one to seven (range=30-210). Higher scores indicate more severe symptoms.
Baseline to post-treatment day 7
Change in Young Mania Rating Scale (YMRS) score
Time Frame: Baseline to post-treatment day 7
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. The items are selected based upon the core symptoms of mania. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe symptoms.
Baseline to post-treatment day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Rating Scale for Depression (HAM-D)
Time Frame: Baseline to post-treatment day 7
The 17-item HAM-D will be used to rate the severity of depression in subjects who are already diagnosed as depressed. The HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. The HAM-D maximum score is 52 for the 17 items with a higher score indicating more severe symptoms.
Baseline to post-treatment day 7
Change in Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Baseline to post-treatment day 7
The EPDS is a 10-item subject-rated depressive symptom severity scale specific to the perinatal period. The EPDS maximum score is 30 with higher scores indicating more severe symptoms.
Baseline to post-treatment day 7
Change in Clinical Global Impression Scale (CGI)
Time Frame: Baseline to post-treatment day 7
The CGI is a validated scale to allow clinicians to measure a subject's change in illness severity from baseline. The CGI scale consists of three items. Only the first two items (CGI-S and CGI-I) will be used in this study. The CGI-S uses a seven-point Likert scale to rate the severity of the subject's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. The CGI-I employs a seven-point Likert scale to measure the overall improvement in the subject's condition post-treatment. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (very much improved) through to 7 (very much worse).
Baseline to post-treatment day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Sage Therapeutics

Investigators

  • Principal Investigator: Samantha Meltzer-Brody, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Data will be available by investigator request starting 9 months following publication and continue through 36 months afterwards.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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