The Massachusetts General Hospital (MGH) has been chosen by the National Institute of Mental Health as the coordinating center for a national research study into the treatment of bipolar disorder, more commonly called manic-depressive disorder. The study will be supported by a five-year grant of more than $20 million, making it the largest psychiatric clinical research program undertaken anywhere.
The MGH team, led by Gary Sachs, MD, the study's principal investigator, will collaborate with investigators at the University of Pittsburgh, the University of Colorado and nine other centers in a program designed to evaluate existing treatment protocols and speed the process by which treatments are tested and introduced into clinical practice. The goals include improving the diagnosis of patients, testing new medications for bipolar disorder and determining which treatment plans work best for patients in particular situations, and building an informational and organizational structure for future research.
"Our being chosen to lead this project is a tremendous honor," says Edwin H. Cassem, MD, chief of the MGH Department of Psychiatry. "The outstanding work of Dr. Sachs and his colleagues in the MGH Bipolar Program now will be a model for an effort that will improve the care of patients everywhere." The MGH team also includes investigators from McLean Hospital, Brigham and Women's Hospital (BWH) and Harvard Medical School (HMS).
People with bipolar disorder experience extreme mood swings, from excessive "highs" called mania to the dark "lows" of depression. According to the National Depressive and Manic Depressive Association, more than 2 million Americans have bipolar disorder, and as many as two-thirds are undiagnosed, misdiagnosed or poorly treated for a condition that can be life-threatening.
"Without proper treatment, 15 to 20 percent of people with bipolar disorder will die by suicide," says Sachs. "When appropriately treated, their risk is no greater than that of the general population. And treatment also can make a huge difference in people's lives by alleviating symptoms that could ruin their careers and their relationships."
Sachs adds that people with bipolar disorder sometimes are misdiagnosed with depression only (unipolar depression) which may lead to inappropriate treatment, or they may have more subtle symptoms that do not initially look like classic bipolar disorder. "To correctly diagnose this illness, you need to look at the whole spectrum of the patient's moods and behaviors, not just the current episode. That usually means involving a patient's family members and friends, who can help paint a complete picture of what is happening in the patient's life."
Medications available to treat bipolar disorder, primarily lithium and more recently certain anticonvulsant drugs, enable many patients to return to productive lives but are not perfect. Some patients' symptoms improve but do not disappear; others may not respond to any currently approved medication. In addition, patients who remain symptom-free for extended periods of time may be tempted to stop their medication, putting them at risk for relapse.
New medications on the horizon may prove more useful for bipolar patients. In addition, several types of individual and group psychotherapy can provide crucial help and support to bipolar patients and to their family and friends. The challenge facing physicians and patients today is determining which combination of medications, therapy and other interventions would best meet the needs of each individual patient.
"There are about two dozen potential new drugs out there," says Sachs. "Evaluating each of them in separate studies at a lot of different centers would be complex and very time-consuming. This project will establish a framework for coordinated testing of these medications and for quickly sharing new information from the project's research or from studies conducted elsewhere. By basing this project in clincial facilities around the country, we should get a clearer picture of how well particular treatment approaches actually work in real-world situations."
The project will establish 12 treatment centers across the country, at the MGH, Pittsburgh, Colorado and nine additional centers to be chosen in the coming months. The centers' staff psychiatrists and clinical specialists will be trained in the use of diagnostic techniques and treatment guidelines developed within the MGH Bipolar Program. Along with adopting these guidelines, the treatment centers will gather and share data about treatment outcomes in consenting patients and offer patients the opportunity to participate in clinical trials of new medications and treatment protocols.
"Simply implementing the treatment guidelines, which have been supported by national and international experts, should improve the care of about 5,000 patients at the participating centers," Sachs says. "As we refine and improve those guidelines, develop new ones based on studies of new treatments, and share that information with the wider psychiatric community, we hope to impact the care of tens of thousands of patients in the United States and around the world."
Key members of the MGH research team include Lee Cohen, MD, Christina Demopulos, MD, Andrew Nierenberg, MD, Michael Otto, PhD, Mark Pollack, MD, Noreen Reilly-Harrington, MD, and Adele Viguera, MD, at the MGH; Andrew Stoll, MD, at BWH; Ross Baldessarini, MD, John Hennen, PhD, and Roger Weiss, MD, at McLean Hospital; and Richard Frank, PhD, at HMS.