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Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Clinical research trials and Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) clinical trial. Human subjects frequently get the finest healthcare available for their Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)  Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
For Condition: Bipolar Disorder,Mood Disorders,Cyclothymic Disorder,Affective Disorders, Psychotic
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 5000
Location and Contact Information:
Overall Study Official:
GarySachs, Principal Investigator, Massachusetts General Hospital
University of Louisville School of Medicine *No longer recruiting*
Louisville, Kentucky, 40292
United States
No longer recruiting
University of Oklahoma Health Sciences Center *Recruiting*
Tulsa, Oklahoma, 74129
United States
Recruiting Lori Impson 918-660-3117
University of Colorado, Colorado Psychiatric Health Clinical Investigation Center *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Sherri Green 303-315-9645
New York University - Bellevue Hospital Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Alissa Schamber 212-263-6203
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Lori Eisner 617-726-6748
Portland Veteran's Administration Medical Center *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Robert Socherman 503-220-8262
University of Massachusetts Medical Center *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Barbara Corbisier 508-856-1741
University of Texas, San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Martha Dahl 210-567-5421
Howard University *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Elisabeth Brisbane 202-865-1743
University of Missouri *Recruiting*
Kansas City, Missouri, 64108
United States
Recruiting Patricia Harmon 816-512-4579
Stanford University School of Medicine *Recruiting*
Stanford, California, 94305-5723
United States
Recruiting Andrea Alarcon 650-498-4801
University of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Judy Lis 412-624-5110
University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-2649
United States
Recruiting Emily Eisenstein 215-746-6414
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Mood Center 713-798-6663
Case Western Reserve University *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Andrea Confer 216-844-2890
Additional Information:
Study ID Numbers: N01MH80001;
Study Start Date: September 1998
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012558
Other Bipolar Disorder Studies:
1. An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
2. Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms.
3. Bipolar Disorder Study
4. The Treatment of Children and Adolescents with Treatment-Resistant Depression
5. Study of Aripiprazole in Patients with Bipolar I Disorder with a Major Depression Episode
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
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