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

Sponsor

National Institute of Mental Health (NIMH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00012558

Collaborator

(none)

5,000

Enrollment

Locations

Duration (Months)

454.5

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1998

Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305-5723
2	University of Colorado, Colorado Psychiatric Health Clinical Investigation Center	Denver	Colorado	United States	80220
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	University of Massachusetts Medical Center	Worcester	Massachusetts	United States	01655
5	Case Western Reserve University	Cleveland	Ohio	United States	44106
6	University of Oklahoma Health Sciences Center	Tulsa	Oklahoma	United States	74135
7	Portland Veteran's Administration Medical Center	Portland	Oregon	United States	97201
8	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104-2649
9	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900