Open Label Study of the Efficacy, Safety and Tolerability of Zulresso in the Treatment of Adult Women With Postpartum Psychosis
Overview
- Phase
- Early Phase 1
- Intervention
- Brexanolone
- Conditions
- Postpartum Psychosis
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in Positive and Negative Syndrome Scale (PANSS) score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
Open Label - Active Drug
Brexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone.
Intervention: Brexanolone
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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)
- Change in Hamilton Rating Scale for Depression (HAM-D)(Baseline to post-treatment day 7)