Patient Resources for
Postpartum Depression (PPD)
Postpartum Depression (PPD) can affect a mother’s ability to care for her child and may negatively affect a child’s cognitive development. PPD is thought to develop from rapid changes in the levels of endogenous neurosteroids during pregnancy.
Plasma levels of allopregnanolone, which is a metabolite of progesterone and GABA modulator, are known to increase throughout pregnancy and then precipitously drop after delivery. It is thought that these rapid hormonal changes are linked to triggering depression in women who are vulnerable to develop this condition.
The most common medications prescribed to women who seek treatment for PPD are SSRI’s and SNRI’s, which have limited evidence of efficacy. There are currently no approved therapies to treat PPD.
How does PPD affect the body?
PPD is a mood disorder that affects about 15% of women within the first year of childbirth. Women with PPD experience feelings of extreme sadness, hopelessness, suicidal ideation, anxiety, and fatigue. These symptoms mirror those of a major depressive episode with the additional criteria that the onset of depression occurs within 4 weeks of childbirth. PPD can affect a mother’s ability to care for her child and may negatively affect a child’s cognitive development.
Where can I find more information on PDD?
You can find additional educational and support resources on Postpartum Depression through the following foundations and patient advocacy groups:
Links to third party sites are provided for convenience purposes only. The information contained on these sites is not information provided, controlled or monitored by Marinus Pharmaceuticals in any way. Marinus Pharmaceuticals is not responsible in any way for the accuracy, completeness or fitness for any particular purpose of any content appearing on such sites.
Clinical Development of Ganaxolone in Postpartum Depression
Enrollment is complete in the Magnolia study, a Phase 2 double-blind, placebo-controlled, multiple-dose escalation study to evaluate the safety, efficacy, and pharmacokinetics of intravenous (IV) ganaxolone in women with postpartum depression (PPD). The study consists of multiple cohorts of women with a Hamilton Depression Rating Scale (HAMD17) score ≥26. Patients randomized into the first part of the study will undergo an infusion (IV) of either ganaxolone or placebo and will be followed for 30 days. The goal of the first part of the study is to evaluate multiple regimens of intravenous (IV) ganaxolone, which will inform dosing for the second part of the study.
Patients enrolled into the second part of the study could receive IV ganaxolone of various infusion lengths followed by administration of oral ganaxolone (capsule), which will allow the patient/new mother to remain home during the important bonding time with her new child. The goal of the second part of the study is to identify an optimized dose or doses for further testing in phase 3.
Enrollment is also ongoing in the Amaryllis Study, a Phase 2 double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, and efficacy of oral ganaxolone in women with PPD. The study is designed to enroll approximately 50 women at 20 sites within the US. The goal of this study is to determine the oral dosing regimen for future studies.
Liquid Suspension & Oral Dosing
Data were recently published demonstrating that a continuous infusion of allopregnanolone rapidly alleviates symptoms of depression in women with PPD. Ganaxolone, a synthetic analog of allopregnanolone, may provide benefit to these women. Additionally, oral ganaxolone has the potential to provide the largest segment of the PPD patient population with access to convenient, oral outpatient therapy.