A team of medical researchers 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 alleviate the symptoms of postpartum depression. In their study, reported in American Journal of Psychiatry, the group conducted a phase III clinical trial with postpartum women.
Postpartum depression is a mood disorder that affects many women. Its symptoms can include extreme fatigue, low mood, lack of interest and ability to concentrate, and a desire to commit suicide. Previous research has suggested that as many as one in seven women experience some degree of postpartum depression. Currently, there is only one medication available, Zulresso, which is administered intravenously over three days and requires a stay in a health center – 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 several days in a row – typically 15. The drug is not particularly 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 doctor for the next few weeks.
To test the drug’s effectiveness, the researchers recruited 170 women who had recently given birth and who had previously been diagnosed with severe postpartum depression. Half of the volunteers received the drug, the other half a placebo.
The researchers found that all of the women in the study saw improvements in their symptoms, but only those given the drug reported significant improvements, and only those women experienced continued improvements for four to six weeks.
It is likely that the women who received the placebo saw improvements in symptoms while in the study because of other types of care they received, such as respite from childcare. The FDA is reviewing the drug and is expected to decide whether or not to approve it 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
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