A $12.9 million funding award is enough to make any research study stand out. But what really distinguishes a new study of strategies for minimizing obesity and weight gain in children with bipolar disorders is the collaborative approach, from start to finish.
The study, titled "MOBILITY: Improving Patient-Centered Outcomes Among Overweight and Obese Youth with Bipolar Spectrum Disorders Treated with Second-Generation Antipsychotics,” was approved last week for the award from the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit organization authorized by Congress in 2010. It will assess whether healthy lifestyle interventions plus the diabetes drug metformin are more effective than lifestyle interventions alone in reducing weight gain and metabolic problems and improving the mental health of overweight and obese youth with bipolar disorders.
Studies have shown that patients with bipolar disorder are at greater risk than the general population for being overweight and obese, partly because of treatment with medications associated with weight gain.
Melissa DelBello, MD, will be the principal investigator at UC for the study, which will also involve researchers at Cincinnati Children’s Hospital Medical Center and Long Island Jewish Medical Center in New York. DelBello is the Dr. Stanley and Mickey Kaplan Professor and Chair of the Department of Psychiatry and Behavioral Neuroscience at the UC College of Medicine, a UC Health psychiatrist and co-director of the Mood Disorders Center at the UC Neuroscience Institute.
Michael Sorter, MD, a professor in the UC Department of Pediatrics and director of the Division of Psychiatry at Cincinnati Children’s, will be leading the efforts at Cincinnati Children’s and Christoph Correll, MD, a professor of psychiatry and molecular medicine at Hofstra North Shore-Long Island Jewish School of Medicine in New York, will be leading efforts at Long Island Jewish Medical Center.
The study was among five awards totaling nearly $58.5 million that PCORI approved to fund patient-centered clinical comparative clinical effectiveness research (CER). All five, plus 29 other awards totaling nearly $61.6 million, were approved by PCORI’s board pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.
DelBello says MOBILITY grew out of conversations with John Hutton, MD, a professor of pediatrics at UC and associate dean for information services at the College of Medicine who, in DelBello’s words, "inspired us to dream the impossible” with an ambitious, team-oriented proposal.
Hutton recalls that he had been exploring opportunities in mental health research at Cincinnati Children’s and was struck by the number of children who required both psychiatric care and drug therapy. "As is frequently the case with childhood disorders, there are few rigorous studies that identify the best drug therapy for individual patients and ways to predict and prevent side effects that the patient will generally experience from specific drugs,” Hutton says.
Hutton arranged a meeting with DelBello, whom he knew to be a nationally respected leader in bipolar disorder and clinical research, and suggested that she consider pulling together and leading a collaborative team of researchers from UC and Cincinnati Children’s to study how best to manage children with bipolar disorder.
"To judge the efficacy of treatment and prevention of side effects, it was essential to have input from patients, family and others,” Hutton says. "This seemed to be an ideal project to request funding from PCORI.”
PCORI’s mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed health care decisions. While traditional medical research is obviously important, PCORI says, "pragmatic” studies are needed to answer pressing clinical questions in the real-world setting where care occurs.
"We’re excited about the important patient-centered questions that these studies aim to answer, PCORI Executive Director Joe Selby, MD, said in last week’s announcement. "We’re also particularly excited about the partnerships that the research teams are forming with key patient groups and other stakeholder organizations.
"This kind of engagement can lead to greater attention to the outcomes that matter most to patients and those who care for them and foster quicker dissemination and application of study results.”
The MOBILITY study team is composed of patients and their family members, representatives of national advocacy groups and major third-party payers as well as academic researchers. MOBILITY is partnering with numerous regional and national mental health facilities, including Lindner Center of HOPE (co-owned by UC Health and the Lindner Family Foundation), community mental health sites and agencies such as the Depression and Bipolar Support Alliance (DBSA) and NAMI (National Alliance for Mental Illness) Southwest Ohio and the American Academy of Child and Adolescent Psychiatry.
The study’s "patient-centered” design and outcome measures were determined over months of intensive meetings and research to ensure that they address the questions that patients and families identify as most important to them. For example, surveys conducted with help of DBSA and NAMI identified weight gain as the most troubling side effect of second-generation antipsychotics and the principal reason why many patients do not adhere to these effective mood-stabilizing treatments.
"We’re excited about the partnership aspect of this study,” says Heather Turner, executive director of NAMI Southwest Ohio. "Our organization has a long history of working with UC, UC Health and Cincinnati Children’s, and this is a natural next step in our relationship. We look forward to being engaged every step of the way.”
Over 20 clinical sites, many based in community settings rather than academic research centers, will participate in the MOBILITY study. Unlike many traditional clinical trials whose tightly controlled procedures do not necessarily resemble usual treatment practices, MOBILITY will closely simulate typical clinical conditions by enrolling a broad range of patients and imposing few restrictions on their care.
To accommodate this increased variation, MOBILITY will employ cutting-edge statistical methods to understand how treatment outcomes relate to each other and whether they differ among clinical and demographic subgroups. Co-investigator Jeff Welge, PhD, an associate professor in the UC Department of Psychiatry and Behavioral Neuroscience, will lead a group of biostatisticians and data management experts from UC and Cincinnati Children’s. MOBILITY will also leverage the resources of the Center for Clinical and Translational Science and Training (CCTST), including data collection and management using REDCap, a Web-based software platform.
"We’re really excited to have this opportunity to systematically evaluate strategies to help children with bipolar spectrum illnesses improve their mental and physical health,” DelBello says. "As we implement this important study over the next five years, we look forward to the continued input and involvement of patients, families and other stakeholders.”