An experimental intravenous drug relieved post-partum depression (PPD) in 7 out of 10 women participants, according to results of a small Phase II clinical trial. Results occurred within an unprecedented 60 hours of treatment and continued for at least one month.
P“This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date,” said primary investigator Samantha Meltzer-Brody, MD, MPH, Associate Professor and Director of the Perinatal Psychiatry Program at the University of North Carolina Center for Women’s Mood Disorders, in Chapel Hill, NC.
“The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date,” she added. “The data show the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”
No currently approved therapies are available specifically for PPD, and therapeutic options for severe PPD are few, the investigators noted.
For this randomized, multi-center, placebo-controlled trial, Dr. Meltzer-Brody and colleagues recruited 21 women who developed severe depression at any point between the third trimester and four weeks after childbirth. The researchers defined severe PPD as a score of 26 or more on the Hamilton Rating Scale for Depression (HAM-D). At baseline, average HAM-D scores were greater than 28 for both groups.
Investigators administered the drug SAGE-547 in 10 patients and a placebo injection in 11 patients. Of the 10 patients in the treatment group, 7 had a reduction in HAM-D score of more than 20 points at 60 hours, compared to 1 patient out of 11 in the placebo group. These 7 patients remained in remission for the 30 days of the trial.
SAGE-547, developed by Sage Pharmaceutical, is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. It’s a synthetic version of the neurosteroid hormone allopregnanolone, which appears to decrease significantly after childbirth, causing postpartum depression in some women.
Results showed the drug was generally well-tolerated with no serious adverse events.
“The difference between this [drug] and something else that has too-good-to-believe results is the pharmacology is probable,” Jeffrey Lieberman, MD, the Lawrence C. Kolb Professor and Chairman, Department of Psychiatry, Columbia University College of Physicians and Surgeons, told Forbes. “I would say it’s exciting, but I certainly wouldn’t say this is definitive or a slam-dunk finding.”
Sage Pharmaceutical is now expanding enrollment of the Phase II trial to include moderate as well as severe patients, with a goal of determining the optimal dose of the drug.