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 Our Goals
This project aims to improve treatment for bipolar mood disorder. The overall goal of the STEP-BD project is to improve treatment of bipolar mood disorder by finding the best way to deliver the most effective treatment available and to provide answers to the many important questions confronting the field.
Since bipolar mood disorder is a complex condition, meeting this goal requires systematic assessment of treatment outcome in a large sample of patients over a long period of time.
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The coordinating center will establish a network of up to 20 treatment centers in which some 5,000 patients will be treated by specially trained psychiatrists and clinical specialists. These practitioners will use common assessment procedures and implement therapeutic
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interventions as called for by treatment guidelines that integrate pharmacological interventions and several psychosocial interventions.
The coordinating center will analyze data from these centers to determine impact of a wide variety of treatments on disease-specific outcomes, quality of life/functional outcome and economic outcomes. Additional data will be collected that are focused on adherence to guidelines, as well as the influence of treatment setting and of regional and ethnic factors on treatment outcomes.
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What will be accomplished?
Implementation of treatment guidelines based on current expert recommendations and systematic assessment techniques will immediately improve the care of thousands of bipolar patients. Over the course of the study, incremental improvement in treatment effectiveness is expected as the coordinating center will revise the guidelines as appropriate to reflect study outcomes and findings from outside studies and newly available therapies. Results of these reviews will be submitted for publication and communicated at scientific meetings. Specifically, the study will determine the most effective treatment for bipolar depression and the best techniques for preventing relapse, and evaluate the psychotropic benefit of new agents such as anticonvulsants, atypical antipsychotics, cholinesterase inhibitors and neurotransmitter precursors. It will also determine the benefit of treatment with combinations of psychotropic agents.
This project will establish a national resource capable of carrying out studies which require large samples of well characterized patients. The coordinating center will evaluate proposals for independently funded projects utilizing the resources of this project (e.g., subjects, tissue samples, database, methodology, training techniques, and software) and facilitate the implementation of appropriate projects.
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Specific Objectives:
STEP-BD will enroll approximately 5,000 people with bipolar disorder to ensure a broad sample inclusive of all bipolar subtypes, ethnic groups and treatment settings.
The proposed studies were designed to address key questions in areas considered to be of major clinical importance. Given the limitations of time and budget, the objectives are designated as primary and ancillary.
The 4 primary objectives of STEP-BD are:
- Implement common clinical practice procedures across a network of clinicians treating large numbers of bipolar patients in diverse treatment settings.
- Determine the most effective strategies for treatment of the depressed phase of bipolar illness.
- Determine which maintenance strategies most effectively prevent recurrence of affective episodes.
- Provide a systematic means for translation of novel treatments and new findings into clinical practice.
The ancillary objectives of STEP-BD include:
- Determine the benefit of specific interventions for bipolar patients with comorbid psychoactive substance abuse or dependence.
- Determine the prognostic significance of common comorbid conditions.
- Determine the benefit of specific interventions for rapid cycling.
- Determine the benefit of specific treatment strategies for acute mania.
- Determine the best treatment for bipolar women who are or want to become pregnant.
- Determine the validity of proposed subtypes of bipolar illness.
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General Approach:
Improved treatment of bipolar illness will be accomplished in four ways:
- Immediate improvement will be achieved by implementing treatment guidelines based on currently available knowledge. The guidelines provided to clinicians in a wide variety of settings will be applicable to patients with all forms of bipolar illness.
- Continuous improvement in the future will result from this work by addressing important fundamental clinical questions, which require the careful investigation that only a study of this scope can provide. Despite the complexity of bipolar mood disorder, large-scale, multicenter, longitudinal studies can provide data required for clinical decision making and improved public health.
- Encourage the development of innovative treatments to improve quality of life and increase the options for patients intolerant to, or refractory to, available therapies.
- Establish a scientific advisory group to evaluate putative treatments. This committee will act to facilitate appropriate testing of promising innovations and serve as a clearing house to check the potentially baseless claims.
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