Postpartum Depression (PPD)

PPD can affect a mother’s ability to care for her child and may negatively affect a child’s cognitive development.

depresia-post-partumPPD 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.

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.

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 an endogenous gamma-aminobutyric acid (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.

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.

Clinical Development for Ganaxolone in PPD

Enrollment is on-going 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 severe PPD. The study consists of multiple cohorts of women with a HAMD17 score >26.  Patients randomized in the initial cohort(s) will undergo an infusion of either ganaxolone or placebo and followed for at least 30 days.  Subsequent cohorts could include shorter- or higher-dose intravenous regimens alone, or in sequential administration with oral ganaxolone.

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Enrollment is on-going in the Amaryllis Study, a Phase 2 clinical trial to evaluate the safety, tolerability and efficacy of oral ganaxolone in women with moderate PPD (HAMD17 score > 20 and < 26). The goal of this study is to determine the oral dosing regimen for future studies. Oral ganaxolone has the potential to provide the largest segment of the PPD patient population with access to convenient, oral outpatient therapy.


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