A team of medical scientists from Sage Therapeutics and Biogen, led by Dr. Kristina Deligiannidis, with the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in New York, has found promising results from a new drug designed to relieve the symptoms of postpartum depression. In their study, reported in the American Journal of Psychiatry, the group conducted a phase III clinical trial with postpartum women.
Postpartum depression is a mood disorder that afflicts many women. Its symptoms can include extreme fatigue, low mood, lack of interest and ability to concentrate, and a desire to commit suicide. Prior research has suggested that as many as one in seven women experience some degree of postpartum depression. Currently, there is just one medication available, Zulresso, which is administered intravenously over three days and requires a stay at a health care facility—an untenable situation for most new mothers.
In this new effort, the research team developed a therapy called Zuranolone; it can be taken in pill form for multiple days in a row—typically 15. Notably, the drug is not an antidepressant; it is a steroid that works to reduce symptoms by balancing the firing of neurons in networks involved in mood and behavior. After two weeks, the patient stops taking them and they check in with their physician for the next few weeks.
To test the effectiveness of the drug, the researchers recruited 170 women who had given birth recently and who were previously diagnosed as experiencing severe postpartum depression. Half of the volunteers were given the drug, the other half a placebo.
The researchers found that all the women in the study saw improvements in their symptoms, but only those who received the drug reported significant improvements, and only those women experienced continued improvements for four to six weeks.
It is likely those women who received a placebo saw improvements in symptoms while in the study due to other types of care they received, such as getting a respite from child care. The FDA is reviewing the drug and is expected to decide whether to approve it or not by August 5.
Kristina M. Deligiannidis et al, Zuranolone for the Treatment of Postpartum Depression, American Journal of Psychiatry (2023). DOI: 10.1176/appi.ajp.20220785
American Journal of Psychiatry
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