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Efficacy vs. Effectiveness Research. In recent years there has been an increasing emphasis on extending clinical trials research - research that examines how well treatments work in patients - from tightly controlled, inpatient hospital settings to settings in the "real world." Many past studies have established the safety and efficacy of various treatments for bipolar disorder - that is, how well they work in very specific groups of patients under ideal conditions. However, few studies have adequately tested the effectiveness of particular treatments or treatment strategies - how well they work, for example, in patients who live in the community, come from diverse backgrounds, have co-occurring illnesses, or experience atypical patterns of manic and depressive episodes. In addition, quality of life, ability to work, social functioning, treatment adherence, and treatment cost-effectiveness are among the important, real world issues that only effectiveness research can adequately assess. In contrast to efficacy research, effectiveness studies have very few exclusionary criteria and enroll very large numbers of participants - several hundred to thousands - so that the findings will be representative of and broadly applicable to an entire population group.
To improve the standards of treatment for bipolar disorder, NIMH has taken the lead in treatment effectiveness research on this illness. Major goals are:
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to establish treatment effectiveness both in the short and long term;
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to develop guidelines for treating patients who do not respond to standard single therapies;
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to evaluate combinations of pharmacological and psychosocial treatments;
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to define a core set of outcome measures to make findings across studies comparable; and
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to translate research findings more quickly into routine clinical practice.
NIMH recently awarded a multi-million dollar contract for a bipolar disorder research study designed to achieve these goals. The study is called the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).
The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
STEP-BD is a large-scale, 5-8 year clinical study being conducted at 20 sites across the U.S. to determine the most effective treatment strategies for people with bipolar disorder. The study will evaluate both individual and combined pharmacological and psychosocial treatments.
Because STEP-BD is an effectiveness study, there are very few exclusionary criteria. Anyone who is age 15 or older and formally diagnosed with bipolar disorder is eligible. (Individuals younger than 18 need parental consent to participate.) In addition, individuals may join the study during any phase of their illness, whether or not they are currently in treatment, and whether or not their symptoms are controlled.
STEP-BD offers all the standard treatment options used for bipolar disorder. The aim is to examine existing, efficacious treatments to come up with the best set of strategies for tackling this very complex illness. Participants may choose their own preferred treatment plan with their study doctor or may decide to have treatments chosen for them through a randomization process. Randomized treatment "pathways" were built into the study to compare competing treatment strategies where existing guidelines and expert recommendations offer no clear treatment of choice. Either way, all participants will always receive active treatment with one or more mood stabilizing medications. Placebos (inactive pills) will never be used alone in any part of the study but may be used in combination with a mood stabilizer for limited periods during the randomized treatment pathways. The investigators will track participants for up to 8 years to document and evaluate long-term treatment outcome. More information about NIMH clinical trials can be obtained by accessing the NIMH home page at www.nimh.nih.gov/studies/index.cfm or the National Library of Medicine clinical trials database at www.clinicaltrials.gov.
Sleep Loss and Social Rhythms
Findings from NIMH-supported research indicate that sleep deprivation can trigger a manic episode in some people with rapid-cycling bipolar disorder. For reasons that are still unknown, people with bipolar disorder appear to have very delicate "internal clock" mechanisms, and disruption of these mechanisms by losing even a single night's sleep often results in mania. Developing and adhering to a structured daily routine and sleep schedule may help protect against mood disturbances. NIMH researchers are investigating the independent effects of the internal clock and the sleep-wake cycle on mood in patients with rapid-cycling bipolar disorder.
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