Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211263
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2005-09-13
Brief Title:
Bipolar Disorder Research Study for Ages 12 and Older
Sponsor:
Kupfer David J MD
Organization:
Kupfer David J MD
Study Overview
Official Title:
Bipolar Disorder Center for Pennsylvanians BDCP Research Study
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Bipolar disorder is one of the worlds 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SAP 4100010612 | None | None | None |