Every year an estimated 600,000 women experience postpartum depression or PPD within six months of giving birth. Not to be confused with the Baby Blues, which is usually a temporary experience, PPD is a serious condition that can disrupt the daily life of a family and lead to a deterioration of quality of life for those affected. That’s why the research community is pretty stoked about news out of Copenhagen that there is an exciting new drug that is showing encouraging signs of helping moms beat PPD.
The drug, called SAGE-217, just finished a phase three trial and was shown to have had significantly better results at reducing depressive symptoms than the placebo after two weeks of use. Not only that but SAGE-217 also shown to have higher remission rates than the placebo, which means that it was able to keep depressive symptoms away longer.
This is stunning news to researchers including the lead author of the trials, Dr. Eduard Vieta, MD, PhD who is also chair of the Department of Psychiatry and Psychology at the University of Barcelona Hospital Clinic in Spain. He told attendees at the 32nd European College of Neuropsychopharmacology (ECNP) Congress where the trial results were shared that SAGE-217 is “highly effective, with an effect size that was larger than what we usually see with antidepressants.”
Currently, PPD is treated through cognitive behavioral therapy in tandem with prescribed medications called SSRI or Selective Serotonin Reuptake Inhibitors, which act to increase the levels of serotonin in the brain to make a person feel better. SAGE-217 seeks to correct a something called GABA function, which is what researchers think causes PPD and major depression.
In PPD, the areas of brain function that are affected, researchers think, include endocrine, stress, inflammation, epigenetic factors, and the neuroactive steroid neural network, which all rely on something called GABA function to keep things running smoothly. When GABA doesn’t work right, according to this hypothesis, the whole system begins to fail leading to a depressive episode. SAGE-217 might be the drug to help support GABA function preventing the failures that lead to a depressive episode.
The phase three drug trial that is giving researchers so much hope included more than 150 women between the ages of 18 and 45 and who 6 months or less postpartum and had been diagnosed with PPD. The women were in a double-blind study and thus were randomly assigned either the drug SAGE-217 or a placebo once daily for 14 days. After 45 days, the women who were given the drug showed significant gains in remission over those who took the placebo.
Typically, there are four phases to the drug trial process. By the time a potential new drug reaches stage three, it can advance to FDA approval as long as there are no significant side effects that pose a danger to patients. By the time a drug reaches stage four it has generally been approved by the FDA.
More About Post-Partum Depression:
- My Post-Partum Depression Was So Severe I Didn’t Recognize Myself
- Post-Partum Depression and Anxiety: An Open Letter to the Partners
- Alanis Morisette Opens Up About Battling Postpartum Depression