STEP-BD study

Nowhere are these transitions more apparent than in the design of three important studies sponsored by the National Institute of Mental Health. One—the STAR D study—is discussed in detail in Chapter 3. The other two, the CATIE study and the STEP-BD study, are reviewed briefly here as an illustration of current trends in psychiatric research. These three studies break new ground in the sense that they go beyond the concept of efficacy that is established in the industry-sponsored studies The drug is shown to be efficacious for a certain disorder, but in the real world, will physicians prescribe it and will patients take it and stay on it The answer to these questions centers on the concept of effectiveness. An effective drug is one that not only has efficacy against a certain malady but also is accepted by patients because its safety, tolerability, mode and frequency of administration, price, taste, appearance, and so on. These issues are commonly left unexamined in the classic drug trials. 

The STEP-BD study (Systematic Treatment Enhancement Program for Bipolar Disorder) will enroll 5,000 patients in about 20 centers nationwide (the reader will be reminded that pharmaceutical company studies typically enroll several dozen subjects in phase II studies and several hundreds in phase III studies). It includes all bipolar subtypes, various ethnic groups, and a variety of treatment settings. Several aims are pursued in this study the implementation of common clinical practice procedures in diverse settings, the determination of effective strategies for bipolar depression, and the determination of the most effective strategies in preventing relapses. 

---