The human brain is a marvelous, complex organ. It controls so much of the body, and yet so little is known about it. But every day, new research opens doors to the brain’s inner workings, shedding light on the intricacies of diseases and disorders that affect it.
PRA Health Sciences’s Brain Talk series zeroes in on three areas of mental health that have a significant impact on brain research today. Read on for part I of the series, depression and bipolar disorders.
More than 5.7 million Americans have been diagnosed with a bipolar disorder, and roughly 16 million American adults are affected by depression. With such large numbers—which are expected to climb—the time for better treatments is now.
But conducting the trials needed to make the discoveries that will impact those affected by these mental health conditions can be challenging. Issues around subject selection are rife, and better markers to determine diagnoses need to be standardized.
Drawing the map toward discovery
While countless advances have bounded to the forefront of depression and bipolar treatments over the past decade, more, continuous research is still needed. And it starts with clinical research becoming synonymous with treatment options for these disorders.
“We promote the concept of clinical research as a treatment option,” says Dr. Fred Lewis, director of scientific affairs for PRA Health Sciences. “Getting in a clinical trial can be a good way to not only help us advance the science, but also it can be beneficial to the patient.”
He notes that the successful studies are those that provide a true measurable benefit to the patient over current available options. But getting to that point must start with better patient outreach. “We need to do a better job in supporting the research sites that are out there,” Dr. Lewis says. These include university sites as well as the office-space physician, and the commercial sites that are participating in clinical research. Helping those sites better identify patients for trials and educating the public on the availability of trials is essential. “Too long people have looked at clinical trials and thought, ‘I don’t want to be your guinea pig,’ and we need to change that narrative,” Dr. Lewis adds.
“People need to know that the treatments currently available are an option because people in the past have volunteered to be in clinical trials,” notes Dr. David Krefetz, medical director of the Early Development Service research unit at PRA. “To increase our knowledge and increase our therapeutic options, we still need more people to volunteer for trials,” he says. “And there’s inherent value to volunteering, in that clinical research can sometimes act as a care option for those with depression or bipolar disorders, where there otherwise would be no option. You’re provided with an excellent diagnostic evaluation, an education about your illness, and the chance to partake in the most advanced, cutting-edge types of treatment,” Dr. Krefetz says.
As a leader in mental health research, PRA is introducing new avenues to better mental health research, with the launch of virtual clinical trials where patients are enrolling, getting consented, and being interviewed entirely remotely. Patients in Denver can participate in a clinical trial running in Fort Lauderdale, with videos explaining the trial, and smartphone applications uploaded to their phones to allow them to answer different clinical outcome measure scales and alert investigators to their progress.
The placebo response
As more efforts are put toward engaging patients in research studies, investigators must remain vigilant on a common pitfall of these studies: the placebo response. Dr. Krefetz notes that many of the development failures of compounds are due to a high placebo response.
“We see a lot of patients suffering with these mental illnesses in the community,” Dr. Krefetz says. “And it’s difficult to properly engage them at the appropriate stage of their illness.” Dr. Krefetz suggests that because of issues of placebo control, the trials get more complicated; it’s more of a time commitment. “I think we’re trying to change some of that with the use of technology and moving toward mobile applications.” Dr. Lewis notes that PRA has adopted several strategies to mitigate the placebo response, including educating patients and physicians, training raters to more accurately and reliably assess patients across the time of the clinical trial, and keeping the number of raters to a minimum.
“Sometimes these things have an impact and other times it seems that the placebo gets the best of us and is pretty durable to our efforts to reduce it,” Dr. Lewis says.
Moving forward, making strides
“Many people suffering from depression or bipolar disorders are successfully treated with medication,” notes Dr. Krefetz. “The sad mood, poor energy, poor concentration, feelings of guilt or worthlessness and suicidal ideas can all be eliminated with the right medication. But it has to be done in the right context,” he says, adding that medication in the context of psychosocial interventions with the subject, for example, or even social interventions could be helpful with some patients.
But the simple fact remains that more trials are needed because there are still patients who are not getting better. For that, providing new channels for participation, and mitigating common pitfalls of trial execution are needed to take the opportunity for discovery and turn it into reality.
Next up: Part II of the Brain Talk series--Pain medication and substance abuse and the brain.