STEP-BD is the largest treatment study ever conducted for bipolar disorder. It is a long-term outpatient study (5 years) that aims to find out which treatments, or combinations of treatments, are most effective for treating episodes of depression and mania and for preventing recurrent episodes. In addition, the study will evaluate treatment effectiveness in terms of quality of life, adherence to treatment, ability to work, social functioning, and treatment cost-effectiveness. While many treatments are used currently for bipolar disorder, including medications and psychotherapies, doctors are uncertain which of these treatments or combination of treatments actually work best. Findings from STEP-BD will help improve the treatment standards used by doctors in everyday clinical practice.

Condition	Treatment or Intervention
Mood Disorders Affective Disorders, Psychotic Bipolar Disorder Cyclothymic Disorder	Drug: lithium  Drug: valproate  Drug: bupropion  Drug: paroxetine  Drug: lamotrigine  Drug: risperidone  Drug: inositol  Drug: tranylcypromine  Behavior: Cognitive Behavioral Therapy  Behavior: Family-focused Therapy  Behavior: Interpersonal and Social Rythyms Therapy

Further Study Details: 

Expected Total Enrollment:  5000

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.

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

Criteria

General Inclusion Criteria:

• current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);
• able to give informed consent for data to be harvested;
• meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;
• undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;
• meet with Clinical Specialist as scheduled;
• able to complete all Study Registry Forms within 3 months of registration.

General Exclusion Criteria:

• unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);
• not competent to give informed consent in the opinion of the investigator (e.g., psychotic).

Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.

For more information, call toll-free:      1-866-240-3250    stepbd@mailcity.com
As of October 2004, STEP-BD will be enrolling on a limited basis.    

California
      Stanford University School of Medicine, Stanford,  California,  94305-5723,  United States; Recruiting
Colorado
      University of Colorado, Colorado Psychiatric Health Clinical Investigation Center, Denver,  Colorado,  80220,  United States; Recruiting
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
      University of Massachusetts Medical Center, Worcester,  Massachusetts,  01655,  United States; Recruiting
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma Health Sciences Center, Tulsa,  Oklahoma,  74135,  United States; Recruiting
Oregon
      Portland Veteran's Administration Medical Center, Portland,  Oregon,  97201,  United States; Recruiting
Pennsylvania
      University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-2649,  United States; Recruiting
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Texas
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Gary Sachs, M.D.,  Principal Investigator,  Massachusetts General Hospital   
Michael Thase, M.D.,  Principal Investigator,  University of Pittsburgh   

Study ID Numbers:  N01MH80001
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  March 13, 2001
ClinicalTrials.gov Identifier:  NCT00012558
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08