Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

Condition(s) targeted: Bipolar Disorder

Intervention: lithium (Drug); valproate (Drug); bupropion (Drug); paroxetine (Drug); lamotrigine (Drug); risperidone (Drug); inositol (Drug); tranylcypromine (Drug); Cognitive Behavioral Therapy (Behavioral); Family-focused Therapy (Behavioral); Interpersonal and Social Rhythms Therapy (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Gary Sachs, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
Michael Thase, M.D., Principal Investigator, Affiliation: University of Pittsburgh

A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.

Official title: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

Study design: Treatment, Randomized, Double-Blind, Placebo Control

Detailed description: 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.

Minimum age: 15 Years. Maximum age: N/A. Gender(s): 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.

Stanford University School of Medicine, Stanford, California 94305-5723, United States

University of Colorado, Colorado Psychiatric Health Clinical Investigation Center, Denver, Colorado 80220, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Massachusetts Medical Center, Worcester, Massachusetts 01655, United States

Case Western Reserve University, Cleveland, Ohio 44106, United States

University of Oklahoma Health Sciences Center, Tulsa, Oklahoma 74135, United States

Portland Veteran's Administration Medical Center, Portland, Oregon 97201, United States

University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104-2649, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Click here for more information about the study

Related publications:

Sachs GS, Thase ME, Otto MW, Bauer M, Miklowitz D, Wisniewski SR, Lavori P, Lebowitz B, Rudorfer M, Frank E, Nierenberg AA, Fava M, Bowden C, Ketter T, Marangell L, Calabrese J, Kupfer D, Rosenbaum JF. Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD). Biol Psychiatry. 2003 Jun 1;53(11):1028-42. Review.

Sachs GS, Guille C, McMurrich SL. A clinical monitoring form for mood disorders. Bipolar Disord. 2002 Oct;4(5):323-7.

Sachs GS. Strategies for improving treatment of bipolar disorder: integration of measurement and management. Acta Psychiatr Scand Suppl. 2004;(422):7-17.

Thase ME, Bhargava M, Sachs GS. Treatment of bipolar depression: current status, continued challenges, and the STEP-BD approach. Psychiatr Clin North Am. 2003 Jun;26(2):495-518. Review.

Perlick DA, Wolff N, Miklowitz DJ, Menard K, Rosenheck RR, & STEP-BD Family Experience Collaborative Study Group [abstract]. Development of an Integrated Model of Family Burden in Bipolar Illness. The Journal of Mental Health Policy and Economics 6(Supplemental): 37, 2003.

Gray SM, Frankle WG, Sachs GS. STEP BD: A design for evaluating effectiveness of treatment for bipolar disorder. The Economics of Neuroscience 3(1): 65-68, 2001.

Starting date: September 1998
Ending date: September 2005
Last updated: May 3, 2007