In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of severe postpartum depression. SAGE-547, now called brexanolone, is a new type of antidepressant: a formulation of allopregnanolone, which is an endogenous, naturally occurring neuroactive steroid and a metabolite of progesterone. Data from the most recent study of brexanolone was just published in Lancet.
This was a Phase 2 clinical trial of SAGE-547 for the treatment of severe postpartum depression. The women included in this placebo-controlled, double-blind, randomized trial had severe depressive symptoms with a score of at least 26 on the Hamilton Depression Rating Scale (HAM-D). The participants were randomized to receive either SAGE-547 (n=10) or placebo (n=11) as a blinded intravenous infusion taking place over 60 hours.
The results were pretty dramatic. At 24 hours, participants receiving SAGE-547 experienced a 19.0 point mean reduction in their HAM-D scores (p=0.006), compared to 8.4 points in the placebo group. Seven of the ten participants receiving SAGE-547 achieved remission from depression (as defined as a HAM-D score of < 7) assessed at 60 hours, as compared to 1 of 11 placebo patients (p=0.008).
Although this was a small study, the findings are promising. The women included in this study had severe postpartum depression, and they responded well and quickly (within 24 hours!) to brexanolone. Because traditional antidepressants typically take 2-4 weeks to kick in, an antidepressant agent with rapid onset of action would be particularly appealing to women with severe postpartum depression.
The Center for Women’s Mental Health is now recruiting postpartum women with moderate to severe depressive symptoms for a randomized controlled trial of brexanolone. To participate in this study, women must have moderate to severe depressive symptoms and must be within six months of delivery. To find out more about this study, you can call 617-724-1181 or contact Lauren Claypoole at email@example.com.
For those not located in the Boston area, this study is also being conducted at many sites across the United States. Those interested can look here or call (844) 901-0101 to get more information.
Ruta Nonacs, MD PhD
Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, et al. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jun 12.