Authored by Melissa E. Daley, Communications & Marketing Manager, CISCRP
& Emma Kane, Senior Clinical Research Coordinator, Clinical Operations & Development, Sage Therapeutics
NOTE: CISCRP hosted a 2-part webinar series on postpartum depression (PPD), in collaboration with Sage Therapeutics, Inc. This is Part 2 of a 2-part article series, providing an overview of the second webinar, which focused on PPD, clinical research, and shared perspectives from a PPD survivor/patient ambassador, medical professionals, and a patient advocate. You can access Part 1 of this article series here (link to be created).
“The best-planned life can turn as quickly as a rainstorm on a summer’s day,” shares Chelsie, a PPD (postpartum depression) awareness ambassador and moreover, a survivor. Married to her high school sweetheart, she had accomplished many goals on her way to starting her family: she loved her job as an elementary school teacher, had purchased a home and was financially stable. “Everything fell into place according to plan. Teaching students was my passion, but motherhood was my calling,” explains Chelsie. Three years into their marriage, she and her husband were delighted to learn that Chelsie was expecting. Her pregnancy was typical until her 36th week, when she was diagnosed with pre-eclampsia and put on bedrest until her delivery.
Chelsie gave birth during a storm, “…amid tornado sirens and pounding rain,” she recalls. “Even more miraculous, the sun broke through and created a glorious rainbow just minutes after our son Weston was born.”
But almost immediately, Chelsie felt that something was wrong.
She did not feel an instant connection to Weston and she realized her maternal instinct was not taking over. Instead, Chelsie’s mind was swirling with questions about her baby’s welfare, as well as her own. Her anxiety escalated when her first attempts to nurse Weston were unsuccessful.
Chelsie did not know it yet, but she was beginning her journey with PPD.
A few days later Chelsie returned home with Weston. “I was physically weak and emotionally drained.” Everyday tasks were overwhelming. She was nervous, and her baby could feel her tension. “I was wracked with anxiety. I didn’t feel like I could even hold him,” says Chelsie.
A week after returning home, Chelsie was rushed to the emergency room with a racing heart and unresolved pre-eclampsia. Recognizing that Chelsie needed sleep, her OB/GYN prescribed a sleeping pill. Chelsie and her mother hoped rest would help. Still, she felt that her mind would not rest. “The next night would prove to be the start of the worst time of my entire life. I cried until I couldn’t cry anymore, and what came next was an utter lack of emotion. I knew I wasn’t myself, and I spoke up,” Chelsie shares.
“With my mom, dad, and husband in the living room, I explained I felt no connection to Weston. I felt like a terrible person and mother,” says Chelsie. Her family consoled her as best they could and suggested she speak with a cousin who had suffered with PPD. Her cousin advised Chelsie to call her OB/GYN. Chelsie’s OB/GYN had never treated anyone with PPD, and recommended a psychiatric facility.
“I felt nothing,” Chelsie says, as she left her six-day old son in her mother’s care. After an evaluation at the hospital, she voluntarily checked herself into a psychiatric hospital where she was officially diagnosed with PPD. She was prescribed medications to help with anxiety, depression, and insomnia.
“The longer I stayed (in the hospital), the worse I got,” says Chelsie. She was transferred to a second hospital.
In the span of 30 days, Chelsie had given birth, been diagnosed with PPD and had been a patient in two psychiatric hospitals. But there were glimmers of hope. “Even when PPD broke me down, I was gently reminded of a higher purpose for my life,” recalls Chelsie. Her parents found the right help for Chelsie, and eventually, with an adjustment of medication and the assistance of a mental health professional, Chelsie began to recover.
“I opened up to my doctors and therapists and we built a relationship where I could tell them anything. They helped me find solutions for whatever I was dealing with,” says Chelsie. Her recovery was challenging, but with assistance from her family, she began to focus on the victories she was starting to have as a mother. Returning to teaching scaled Chelsie’s confidence as well. She joined a local PPD support group and met other mothers navigating the same issues.
“Power in community is so precious. The key to my recovery was not a simple one. I needed the right therapy, medication, and family and friends to support me. Recovery takes time. I love my son more than I can put into words. PPD is nothing to be ashamed of or embarrassed about,” says Chelsie.
Chelsie is active in a non-profit organization focused on serving and building community with moms along with providing them with resources for PPD, regardless of their ability to pay.
There is an unmet need in treating PPD. Dr. Bassem Maximos, OB/GYN, explains that “A lot of physicians don’t recognize it (PPD) and even if we do recognize it, it’s difficult to find resources to point our patients to get the treatment they need.”
Standard-of-care options for the treatment of PPD can be outlined in three categories.
“It takes a long time to find that therapist that you can trust, work with, and open your heart and mind to allow them to help you in your journey,” says Dr. Maximos. “It’s an ongoing treatment,” he adds, “and also sometimes you need other supportive therapies with it.” He also explained that unfortunately, it can be challenging to find a therapist, depending upon the community where you live and the resources that are available. In some regions, there are not many mental health professionals, and the few that are in the area may have so many patients that they are not able to assist new ones.
While it may be challenging to find these groups, Dr. Maximos stresses the importance of supportive psychotherapy and mother-infant therapy groups. “We’ve found in our practice if we get moms to see other moms that have gone through the same experience she’s going through, or have experienced PPD, they are more willing to open up and talk about their experiences – it takes away the fear or stigma.”
Peer support can also be found through groups active on social media when it’s difficult to find professional support. The COVID-19 pandemic has scaled the importance of this channel, with the need for social distancing measures to limit the spread of the virus.
“We’re still not screening our moms enough,” says Dr. Maximos. “The American College of Obstetricians and Gynecologists has been putting a lot of effort into encouraging obstetricians and gynecologists to screen for postpartum depression during the pregnancy and afterwards by giving them screening tools.” But there is still progress to be made.
There are organizations working to escalate access to support mothers suffering with PPD.
Tonya Fulwider, Associate Director for Mental Health America of Ohio and Program Director for POEM (Perinatal Outreach & Encouragement for Moms), says “We work with frontline providers, OB/GYNs, pediatricians and home health professionals. We have a team of certified peer support specialists who work as care navigators. We serve as that single-entry point of care for any birthing person who is struggling with a mental or emotional health complication.” The healthcare provider can reach out to the POEM team and directly connect the patient to receive assistance from a care navigator or peer
support specialist. They can offer a menu of options to address their needs, “…recognizing that she is the expert in her life,” says Tonya.
Sage Therapeutics has conducted multiple clinical trials in PPD over the past several years, and is currently conducting a trial studying an investigational oral tablet to treat PPD. A full listing of clinical trials for women with PPD is available at clinicaltrials.gov.
If you’re considering participating in a clinical trial, Dr. Gus Alva, a psychiatrist focusing on neuropsychiatric conditions with over 27 years of clinical trial experience, advises “Always be informed.” He explains that in his practice, they provide patients with a consent form, a standard clinical trial document which explains the trial in detail and confirms a patient’s willingness to take part in the study, and have them take it home with them. They encourage patients to discuss it with their primary care doctor or other professionals in the medical field. “The consenting process,” he adds, “entails pros, cons, alternatives, and being well-educated.”
There is a regulated process that takes place in not just PPD clinical research, but in all clinical trials.
“There are several inclusion and exclusion criteria that are tied to all studies,” explains Dr. Alva. Inclusion and exclusion criteria are requirements that must be met in order to take part in the study. “Going in and getting screened would certainly be a good option.” He adds, “the nice thing about being involved in a clinical trial is that it’s not binding. There’s no penalty to withdrawing consent at any point. It’s a matter of trying to figure out whether this is a good fit or not, but not necessarily feeling that you are now bound to it.”
Individuals considering clinical research should consult the medical professionals involved in their care.
Dr. Maximos explains that before signing up for a clinical trial, “patients should speak to their physician, whether it’s their OB or psychiatrist.” Clinical research sites also conduct outreach efforts to community healthcare providers to raise awareness about clinical research participation opportunities.
“Be a question-asker,” advises Tonya Fulwider, saying that the care navigators she works with often encourage patients to write questions down as they come up so they can address them with their health care providers, whether it’s their OB/GYN, mental health professional or someone on the clinical trial team.
COVID-19 has impacted clinical trials across the board. Very strict guidelines have been put in place at all clinical trial sites, such as taking temperature readings, requiring masks, social distancing, and disinfecting of surfaces continually.
“Individuals that do come in know that we’ve placed into play a lot of different modalities to ensure that there is appropriate disinfecting, minimal touching of door handles or other objects, and that if they’re coming in, there’s a very specific purpose,” Dr. Alva explains. “We take every precaution possible to keep patients safe,” Dr. Maximos adds, including that his entire staff is now vaccinated in addition to the other precautions they’ve put into place over the course of the pandemic.
“Of course, COVID-19 has impacted everything about everyone’s lives, and it certainly has impacted mothers,” says Tonya. “Being able to continue to converse with them and talk about their concerns – that’s really the most important thing.”
To learn more about postpartum depression, access the webinar series, “Postpartum Depression & Being Informed” here. You can also learn more about the Skylark study for PPD here, or access resources from Sage Therapeutics here.
ABOUT SAGE THERAPEUTICS
Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner.
CISCRP (Center for Information and Study on Clinical Research Participation) is a Boston-based, globally focused, non-profit 501(c)(3) organization providing public and patient education and advocacy. CISCRP’s mission is to inform patients and the public about clinical research and the important role that it plays in advancing public health and to help stakeholders in drug development engage with patients and the public as clinical research partners (www.CISCRP.org)