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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. Identifier: NCT00012558
Recruitment Status : Completed
First Posted : March 15, 2001
Last Update Posted : May 4, 2007
Information provided by:
National Institute of Mental Health (NIMH)

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 5000 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Study Start Date : September 1998
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00012558

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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
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
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Principal Investigator: Gary Sachs, M.D. Massachusetts General Hospital
Principal Investigator: Michael Thase, M.D. University of Pittsburgh
Additional Information:
Publications of Results:
Miklowitz DJ, Otto MW. New psychosocial interventions for bipolar disorder: A review of the literature and introduction of the systematic treatment enhancement program. Journal of Cognitive Psychotherapy 2006; 20(2): 215-230.

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00012558    
Other Study ID Numbers: N01 MH80001
First Posted: March 15, 2001    Key Record Dates
Last Update Posted: May 4, 2007
Last Verified: April 2007
Keywords provided by National Institute of Mental Health (NIMH):
Psychotic Disorders
Mood Disorders
Manic-Depressive Illness
Mood Stabilizer
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors