Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00012558|
Recruitment Status : Completed
First Posted : March 15, 2001
Last Update Posted : May 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: lithium Drug: valproate Drug: bupropion Drug: paroxetine Drug: lamotrigine Drug: risperidone Drug: inositol Drug: tranylcypromine Behavioral: Cognitive Behavioral Therapy Behavioral: Family-focused Therapy Behavioral: Interpersonal and Social Rhythms Therapy||Not Applicable|
STEP-BD is evaluating all the best-practice treatment options used for bipolar disorder: mood-stabilizing medications, antidepressants, atypical antipsychotics, and psychosocial interventions - or "talk" therapies - including Cognitive Behavioral Therapy, Family-focused Therapy, Interpersonal and Social Rhythm Therapy, and Collaborative Care (psychoeducation).
There are two kinds of treatment "pathways" in STEP-BD, and participants may have the opportunity to take part in both. The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice.
In the "Best Practice Pathway," participants are followed by a STEP-BD certified doctor and all treatment choices are individualized. Everyone enrolled in STEP-BD may participate in this pathway. Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed. Also, anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway. Adolescents and adults age 15 years and older may participate in the Best Practice Pathway.
For adults age 18 and older, another way to participate is in the STEP-BD "Randomized Care Pathways." Depending on their symptoms, participants may be offered treatment in one or more of these pathways during the course of the study. The participants remain on mood-stabilizing medication. However, because doctors are uncertain which of several treatment strategies work best for bipolar disorder, another medication and/or talk therapy may be added. Each Randomized Care Pathway involves a different set of these additional treatments.
Unlike in the Best Practice Pathway, the participants in the Randomized Care Pathways are randomly assigned to treatments. Also, in some cases, neither the participant nor the doctor will be told which of the different medications is being added. This is called a "double-blind" study and is done so that the medication effects can be evaluated objectively, without any unintended bias that may come from knowing what has been assigned. Participants will not be assigned medications that they have had bad reactions to in the past, that they are strongly opposed to, or that the doctor feels are unsuitable for them. The medication(s) participants may be randomly assigned to in the Randomized Care Pathways are free of charge. There are other treatment options for participants if they do not respond well to the treatment assigned to them. Also, participants may return to the Best Practice Pathway at any time. About 1,500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD.
It is important to note that STEP-BD provides continuity of care. For example, if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways, he or she continues with the same STEP-BD doctor and treatment team. Then, after completing the Randomized Care Pathway, the participant may return to the Best Practice Pathway for ongoing, individually-tailored treatment.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||5000 participants|
|Official Title:||Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)|
|Study Start Date :||September 1998|
|Study Completion Date :||September 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012558
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305-5723|
|United States, Colorado|
|University of Colorado, Colorado Psychiatric Health Clinical Investigation Center|
|Denver, Colorado, United States, 80220|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|University of Massachusetts Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Tulsa, Oklahoma, United States, 74135|
|United States, Oregon|
|Portland Veteran's Administration Medical Center|
|Portland, Oregon, United States, 97201|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104-2649|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Gary Sachs, M.D.||Massachusetts General Hospital|
|Principal Investigator:||Michael Thase, M.D.||University of Pittsburgh|