Bipolar Disorder Research Study for Ages 12 and Older
Bipolar Disorder Research Study for Ages 12 and Older
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.
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.
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.