Clinical trial NCT05314153: Effects Zulresso on Postpartum Psychosis
Official title: Open Label Study of the Efficacy, Safety and Tolerability of Zulresso in the Treatment of Adult Women With Postpartum Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postpartum Psychosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Sage Therapeutics
First posted: 2022-04-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) score
timeFrame: Baseline to post-treatment day 7
measure: Change in Young Mania Rating Scale (YMRS) score
timeFrame: Baseline to post-treatment day 7
Secondary outcomes:
measure: Change in Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Baseline to post-treatment day 7
measure: Change in Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline to post-treatment day 7
measure: Change in Clinical Global Impression Scale (CGI)
timeFrame: Baseline to post-treatment day 7
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samantha Meltzer-Brody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Scott LJ. Brexanolone: First Global Approval. Drugs. 2019 May;79(7):779-783. doi: 10.1007/s40265-019-01121-0.