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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00012558
First received: March 13, 2001
Last updated: May 3, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 5000
Study Start Date: September 1998
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012558

Locations
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
Investigators
Principal Investigator: Gary Sachs, M.D. Massachusetts General Hospital
Principal Investigator: Michael Thase, M.D. University of Pittsburgh
  More Information

Publications:
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00012558     History of Changes
Other Study ID Numbers: N01 MH80001, DSIR AT
Study First Received: March 13, 2001
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):
Psychotic Disorders
Mood Disorders
Manic-Depressive Illness
Hypomania
Mania
Mood Stabilizer

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Valproic Acid
Tranylcypromine
Lithium
Paroxetine
Risperidone
Bupropion
Inositol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antipsychotic Agents

ClinicalTrials.gov processed this record on April 16, 2014