The University of New Mexico Health Sciences Center has received a nearly $2.4 million award to study the safety and effectiveness of bipolar disorder treatments in the United States.
The nationwide study – to be funded over four years by the Patient-Centered Outcomes Research Institute (PCORI) – will compare the outcomes of nine commonly prescribed drugs used to treat bipolar disorder, a lifetime mental illness that causes acute episodes of mania and depression. About six million Americans suffer from the condition.
“There are a lot of gray areas where little is known about the best choice of treatment based on individual characteristics,” says Christophe Lambert, PhD, the study’s principal investigator and an associate professor at the UNM Center for Global Health in the UNM School of Medicine’s Department of Internal Medicine. “It’s a complex disorder.”
One of the challenges of effectively managing it is the oscillating state from extremes of mania to depression. For many, according to Lambert, the euphoric positive emotions experienced during hypomania or mania comes into conflict with treatment adherence.
“Some of the best treatments help keep patients in a stable mood but create a subjective experience of emotional flatness in comparison to their highs,” he says. “On the flipside, with the lows, antidepressants may carry risks with some bipolar disorder patients of inducing mania.”
Unfortunately, according to Lambert, the long term impact of untreated bipolar disorder can be devastating, with research showing that cognitive function declines with each manic episode and that repeated episodes can lead to the condition becoming treatment resistant through a process called kindling.
“When you add in the challenges of drug side effects and treating diverse comorbid conditions, it is clear that better evidence is needed to create more personalized approaches to treatment,” Lambert says.
Over the next four years researchers will analyze de-identified electronic health records of more than a million Americans with bipolar disorder, reviewing their treatments and outcomes over the last decade. “We are going to take real world data and understand how people respond in the context of their conditions,” Lambert says. “The comprehensiveness of this study is unprecedented.”
Some of the treatment outcomes under analysis include frequency of hospitalization, suicide attempts and self-harm, mood episodes and residual symptoms, risk of drug-induced adverse effects and all-cause mortality.
A unique component of the study includes bipolar disorder patients and patient advocacy groups, including the National Alliance on Mental Illness (NAMI) Montana, NAMI New Mexico and NAMI Westside Los Angeles. They are collaborating within a multidisciplinary team of clinicians, researchers, computer scientists and statisticians.
“The study is especially valuable because it will utilize the insights of the medical challenges faced by people who live with bipolar disorder in the rural states of New Mexico and Montana,” says Matt Kuntz, executive director of NAMI Montana. “The complex difficulty of obtaining medical care in rural or frontier states is often not considered in major research studies.”
The study will “benefit patients with bipolar disorders in New Mexico as it will enable us to look at specific therapies that are effective and safe in our ethnically diverse population,” adds Mauricio Tohen, MD, PhD, a co-investigator on the study and chairman of the UNM Department of Psychiatry and Behavioral Sciences.
Scientists will also study drug effectiveness based on gender, age and comorbidities, with particular emphasis on the elderly and children.
“I’ve heard personal stories from parents of children, teenagers and young adults who’ve committed suicide,” says Lambert. “There are a lot of questions about how to treat bipolar disorder over the short and long terms so we can reduce this horrible tragedy that happens all too often.”
The data analysis and input from patient advocacy groups will ultimately help doctors and patients take a step towards evidence-based or personalized medicine, according to Lambert. “If they have better evidence they’ll make better decisions,” he says.
Lambert is leading the study, “Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies,” with co-investigators Tohen, UNM Associate Professor Annette Crisanti, PhD, and Douglas J. Perkins, PhD, director of the UNM Center for Global Health in the School of Medicine’s Department of Internal Medicine.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. It funds research to provide patients, their caregivers and clinicians with the evidence-based information to make better-informed healthcare decisions. UNM Health Sciences Center’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.