An experimental drug touted as a breakthrough for treating severe postpartum depression is showing some promising results in a small clinical trial.
Sage Therapeutics (SAGE), based in Cambridge, Mass., reported on Tuesday that 7 of the 10 women who took the drug in the trial experienced significant improvement in their depression within 60 hours of the injection. That effect was maintained for 30 days.
Among the 11 women who took the placebo, just one experienced remission within 60 hours.
Interestingly, none of the patients who took the drug reported psychiatric side effects, such as abnormal dreams, insomnia, and anxiety — but 5 of the 11 women on the placebo reported such symptoms. A few patients in each group experienced dizziness or a sedative effect.
There’s a natural push and pull between neurotransmitters called NMDA receptors and the GABA receptors that regulate their flow in the brain. In cases of severe depression, that equilibrium gets out of whack, and Sage’s drug is meant to restore it, modulating those GABA receptors to allow NMDA to do its job.
The data could represent a “paradigm shift in how the disease is thought about,” CEO Jeff Jonas said in a conference call.
But before anyone shifts anything, Sage will need more data. The early results are “promising and exciting,” said Dr. Allison Baker, a psychiatrist at Massachusetts General Hospital’s Center for Women’s Mental Health, but “we need to see replication of this data over a much wider range in terms of numbers.”
The study is small and has not been peer-reviewed; Sage disclosed the results in a press release. The company has not submitted study data to federal regulators and isn’t at this point seeking approval of the drug, known as SAGE-547, for postpartum depression. Its next steps: expanding the trial to enroll more women and to determine optimum doses.
“I think it’s incumbent upon us … to find a lower dose that might be just as useful,” especially for nursing mothers, Jonas said.
Women in the trial were asked not to breastfeed for the first 10 days after receiving the injection. The drug has a “very, very short half-life” in the body, Jonas said, meaning that it can be metabolized quickly.
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