What About Clinical Studies for Bipolar Disorder?

Some people with bipolar disorder receive medication and/or psychosocial therapy by volunteering to participate in clinical studies (clinical trials). Clinical studies involve the scientific investigation of illness and treatment of illness in humans. Clinical studies in mental health can yield information about the efficacy of a medication or a combination of treatments, the usefulness of a behavioral intervention or type of psychotherapy, the reliability of a diagnostic procedure, or the success of a prevention method. Clinical studies also guide scientists in learning how illness develops, progresses, lessens, and affects both mind and body. Millions of Americans diagnosed with mental illness lead healthy, productive lives because of information discovered through clinical studies. These studies are not always right for everyone, however. It is important for each individual to consider carefully the possible risks and benefits of a clinical study before making a decision to participate.

In recent years, NIMH has introduced a new generation of "real-world" clinical studies. They are called "real-world" studies for several reasons. Unlike traditional clinical trials, they offer multiple different treatments and treatment combinations. In addition, they aim to include large numbers of people with mental disorders living in communities throughout the U.S. and receiving treatment across a wide variety of settings. Individuals with more than one mental disorder, as well as those with co-occurring physical illnesses, are encouraged to consider participating in these new studies. The main goal of the real-world studies is to improve treatment strategies and outcomes for all people with these disorders. In addition to measuring improvement in illness symptoms, the studies will evaluate how treatments influence other important, real-world issues such as quality of life, ability to work, and social functioning. They also will assess the cost-effectiveness of different treatments and factors that affect how well people stay on their treatment plans.

The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) is seeking participants for the largest-ever, "real-world" study of treatments for bipolar disorder. To learn more about STEP-BD or other clinical studies, see the Clinical Trials page on the NIMH Web site http://www.nimh.nih.gov, visit the National Library of Medicine's clinical trials database http://www.clinicaltrials.gov, or contact NIMH.

This article has been provided by the National Institute of Mental Health, 04/09/2004

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