Bipolar Disorder Research Study for Ages 12 and Older

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: NCT00211263
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 8, 2015
Bristol-Myers Squibb
Eli Lilly and Company
Information provided by:
Kupfer, David J., M.D.

Brief Summary:
The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in treatment results among Pennsylvanians with bipolar disorder, especially among youth, the elderly, rural residents, and African Americans who are less likely to receive adequate treatment, less likely to remain in treatment once identified, and less likely to have positive results if they remain in treatment. Half of the subjects receive either Guideline Intervention (GI) or Enhanced Clinical Intervention (ECI). ECI is a combination of information and support, such as education about bipolar disorder, the medications used to treat it, information about sleep practices and habits that affect quality of sleep, review of symptoms, medication side effects, and coping with side effects. It is predicted that Enhanced Clinical Intervention will be more effective in reducing the differences in results between those most at risk compared to mid-life Caucasians. The treatment study occurs at three sites across Pennsylvania and has emphasized the recruitment of African Americans, youth (ages 12 through 18), and adults over age 65.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Enhanced Clinical Intervention Drug: mood stabilizer Not Applicable

Detailed Description:

Bipolar disorder is one of the world's most disabling conditions, robbing sufferers of years of healthy functioning. The presence of bipolar disorder is not limited to any nation, race, age, gender, or socioeconomic status, and has a lifetime prevalence of 1% across all populations. While there do not appear to be disparities in who is at risk for bipolar disorder, there are marked disparities in who is likely to be diagnosed and treated. The average person with bipolar disorder waits ten years before receiving the correct diagnosis (National Depression and Manic-Depression Association, 2000). Once a diagnosis of bipolar disorder is made, there are equally marked disparities in treatment outcome.

Also known as manic-depressive illness, bipolar disorder is a recurrent and chronic mental condition associated with substantial morbidity and mortality. The stigma associated with open recognition of this disorder decreases the likelihood of accurate diagnosis and treatment. Considering the impact of this disorder on the most vulnerable populations (youth, elderly, rural populations, and minorities), the challenge is to understand and reverse the current public health crisis. This crisis has created an enormous financial burden on the health, welfare, and disability systems. At the same time, it reduces the likelihood of economic and social productivity that can be achieved by potentially productive individuals.

The primary objective of the study is to test an intervention to reduce health disparities related to bipolar disorder, a vastly more destructive and difficult to treat condition than previously realized. The outcomes of interest include accurate and timely diagnosis, adequacy of prescribed treatment, retention in treatment, suicidality, and a range of treatment benefits including health-related quality of life, employment, treatment satisfaction, medication adherence, utilization of lower levels of intervention (e.g., outpatients versus partial or inpatient care), and reduction of substance use, medical morbidity and mortality. Particular attention has been paid to the collection of service utilization data to track key health care and social services. Costs for medical and psychiatric treatment, medications, inpatient, rehabilitation, and emergency room services are being ascertained for cost assessment, and patients' mood functioning is being tracked to assess the overall effectiveness of the interventions. The study is also using state-of-the-art assessments of phenotypic clinical variables to develop clinically meaningful predictors of treatment response across the age spectrum and across diverse racial groups.

To characterize more precisely the phenotypic complexity of this disorder, we have developed a spectrum model of psychiatric illness using a broader conceptualization of mood disorders and an integrated view of common comorbidities, anchored in the Mood and Anxiety Spectrum Assessments (Cassano et al. 1997; Cassano et al in press). This refined description of patient variability (or phenotypes) should lead to improved understanding of the variability in treatment outcomes among patients suffering from bipolar disorder and eventually to creating appropriate first-line treatments for patients who present with specific clinical phenotypes.

Careful consideration of biological phenotypes, as represented in population pharmacokinetics, turns a second line of attack on the problem of tailoring treatments to patients' specific needs. A key correlate of treatment response that has never been examined in bipolar disorder is consistent and adequate medication exposure. Essential to understanding variability in treatment response is being able to distinguish true non-responders from those who never received adequate exposure to drug. Consistency of drug exposure can be determined using a combination of electronic monitoring of drug-taking and population pharmacokinetic analysis.

Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bipolar Disorder Center for Pennsylvanians (BDCP) Research Study
Study Start Date : November 2003
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Enhanced Clinical Intervention Behavioral: Enhanced Clinical Intervention Drug: mood stabilizer
Active Comparator: Clinical Intervention Drug: mood stabilizer

Primary Outcome Measures :
  1. Key outcomes among all enrollments are ascertained every two months and continue throughout the 48-month period of the study. Outcomes include symptom and psychosocial factors, treatment adherence, disease severity, and resource utilization.

Secondary Outcome Measures :
  1. Blood samples are drawn for pharmacotherapy exposure studies for each subject 11 times during the course of the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater than or equal to 12 years.
  • Able to give basic informed consent.
  • Meets DSM-IV Criteria for Bipolar I, Bipolar II (if in the investigator's judgment long term treatment with a mood stabilizer is indicated), Bipolar NOS, or Schizoaffective Bipolar subtype.
  • Because many adolescents have shorter periods of mania or hypomania than those required by the DSM-IV (at least 4 days for hypomania and 7 days for mania) adolescents are included who have a current episode of MDD and a history of episodes mania/hypomania that lasted for at least 2 days.

Exclusion Criteria:

  • Unwilling or unable to comply with study requirements (e.g., complete study forms, attend scheduled evaluations).
  • Not competent to provide informed consent in the opinion of the investigator.
  • Mental retardation (IQ less than 70). Subjects suspected of mental retardation (e.g., chronic academic failure, multiple developmental delays) are evaluated using the Verbal Subtest of the Wechsler Intelligence test.
  • Presence of schizophrenia, schizoaffective pervasive developmental disorder, current substance or alcohol dependence, and organic mental disorder. Substance dependence in early remission is not an exclusion criterion.
  • Unstable medical illness or other medical contraindication to treatment with mood stabilizers, antidepressants or antipsychotic medications.
  • Women who are planning to become pregnant, pregnant or breast-feeding.

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): NCT00211263

United States, Pennsylvania
DuBois Regional Medical Center
DuBois, Pennsylvania, United States, 15801
Thomas Jefferson University University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Kupfer, David J., M.D.
Bristol-Myers Squibb
Eli Lilly and Company
Principal Investigator: David J Kupfer, MD University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00211263     History of Changes
Other Study ID Numbers: ME# 02-385
SAP# 4100010612
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: June 2005

Keywords provided by Kupfer, David J., M.D.:
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders