Brexanolone therapy for moms with postpartum depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating LPCN 1154A as a potential treatment for severe postpartum depression. Participants are adult women up to 45 years old who developed depression around the time of delivery and are within 18 months postpartum, with a high HAM-D score. The study compares LPCN 1154A to placebo to assess efficacy and tolerability, including side effects. Key exclusion criteria include certain psychiatric histories and active psychosis or recent seizure. The trial is sponsored by Lipocine Inc. and conducted at three Lipocine investigational sites in Arizona and California.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Are female between 15 and 45 years of age, inclusive;
* Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery
* Are \< 18 months postpartum at Screening
* Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression

Key Exclusion Criteria:

* Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
* Are currently experiencing active psychosis per Investigator assessment
* Have a history of suicidal behavior associated with the current depressive episode
* Have a history of seizure within six months of Screening

Where it's running

• Lipocine Investigational Site
  Tucson, Arizona, United States Recruiting
• Lipocine Investigational Site
  Canoga Park, California, United States Recruiting
• Lipocine Investigational Site
  Walnut Creek, California, United States Recruiting
• Lipocine Investigational Site
  Aurora, Colorado, United States Recruiting
• Lipocine Investigational Site
  Decatur, Georgia, United States Recruiting
• Lipocine Investigational Site
  Idaho Falls, Idaho, United States Recruiting

Study contacts

• Study coordinator: Vice President of Clinical Development
• Email: siteinquiry@lipocine.com
• Phone: 801-519-4363

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.