Effects Zulresso on Postpartum Psychosis

NCT05314153 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 20-0812
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Psychosis

Outcome Measures

Primary Outcomes (2)

• Change in Positive and Negative Syndrome Scale (PANSS) score

  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

  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 Outcomes (3)

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

  Baseline to post-treatment day 7

• Change in Edinburgh Postnatal Depression Scale (EPDS)

  Baseline to post-treatment day 7

• Change in Clinical Global Impression Scale (CGI)

  Baseline to post-treatment day 7

Study Arms (1)

Open Label - Active Drug

EXPERIMENTAL

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

Drug: Brexanolone

Interventions

Brexanolone DRUG

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.

Also known as: Zulresso

Open Label - Active Drug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Sage Therapeutics: collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (4)

• Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, Arnold R, Schacterle A, Doherty J, Epperson CN, Deligiannidis KM, Riesenberg R, Hoffmann E, Rubinow D, Jonas J, Paul S, Meltzer-Brody S. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jul 29;390(10093):480-489. doi: 10.1016/S0140-6736(17)31264-3. Epub 2017 Jun 12.

  PMID: 28619476 BACKGROUND

• Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31. Erratum In: Lancet. 2018 Sep 29;392(10153):1116. doi: 10.1016/S0140-6736(18)32288-8.

  PMID: 30177236 BACKGROUND

• Kanes SJ, Colquhoun H, Doherty J, Raines S, Hoffmann E, Rubinow DR, Meltzer-Brody S. Open-label, proof-of-concept study of brexanolone in the treatment of severe postpartum depression. Hum Psychopharmacol. 2017 Mar;32(2):e2576. doi: 10.1002/hup.2576.

  PMID: 28370307 BACKGROUND

• Scott LJ. Brexanolone: First Global Approval. Drugs. 2019 May;79(7):779-783. doi: 10.1007/s40265-019-01121-0.

  PMID: 31006078 BACKGROUND

MeSH Terms

Interventions

brexanolone

Study Officials

• Samantha Meltzer-Brody, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: February 23, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available by investigator request starting 9 months following publication and continue through 36 months afterwards.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)