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Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007761
  Purpose

Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.


Condition Intervention Phase
Bipolar Disorder
Behavioral: Usual (psychiatric) Care
Behavioral: Bipolar Disorder Program
Phase III

MedlinePlus related topics:   Bipolar Disorder   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   CSP #430 - REDUCING THE EFFICACY-EFFECTIVENESS GAP IN BIPOLAR DISORDER

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   382
Study Start Date:   July 1997
Estimated Study Completion Date:   December 2003

Detailed Description:

Primary Hypothesis: The primary hypotheses are that Bipolar Disease Program (BDP) intervention will significantly improve (1) manic and (2) depressive symptom scores, as well as Total Treatment Costs as compared to usual care of bipolar patients.

Secondary Hypothesis: Secondary hypotheses include significant improvement in BDP patients as compared to usual bipolar treatment care with respect to functional outcome, quality of life, intensity of somatotherapy, patient satisfaction, and provider attitudes.

Intervention: Usual (psychiatric) Care vs Bipolar Disorder Program

Primary Outcomes: The primary outcomes are: (1) Manic Symptom Score; (2) Depressive Symptom Score; and (3) Total Treatment Costs.

Study Abstract: Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.

Patients with bipolar disorder will be randomly assigned to either standard care or the high intensity ambulatory program for three years. Outcome variables will cover three distinct domains: disease-specific outcome (number, length, and severity of manic and depressive episodes), functional outcome (social and occupational role function and subjective quality of life), and total treatment costs (direct treatment costs and indirect costs of illness). Preliminary data indicate that these domains are related but not redundant. Each of these is relevant to patient well-being and to VHA management.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Patients with bipolar disorder. Index episode of manic, major depression or both requiring hospitalization on acute unit. At lease two hospitalizations, three or more months apart within the past 5 years.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007761

Locations
United States, Arizona
Vamc - Tucson, Az    
      Tucson, Arizona, United States, 85723
United States, California
Vamc - San Diego, Ca    
      San Diego, California, United States, 92161
Vamc - West Los Angeles, Los Angeles, Ca    
      Los Angeles, California, United States, 90073
Vamc - Palo Alto, Ca    
      Palo Alto, California, United States, 94304
United States, Colorado
Vamc - Denver, Co    
      Denver, Colorado, United States, 80220
United States, Connecticut
Vamc - West Haven, Ct    
      West Haven, Connecticut, United States, 06516
United States, Georgia
Vamc - Augusta, Ga    
      Augusta, Georgia, United States, 30904
United States, Illinois
Vamc - Edward Hines, Jr. Hine, Il    
      Hines, Illinois, United States, 60141
United States, Indiana
Vamc - Richard L. Roudebush, in    
      Indianapolis, Indiana, United States, 46202
United States, Ohio
Vamc - Cleveland (Wade Park/Brecksville)    
      Brecksville, Ohio, United States, 44141
United States, Tennessee
Vamc - Mountain Home, Tn    
      Mountain Home, Tennessee, United States, 37684
United States, Texas
Vamc - Dallas, Tx    
      Dallas, Texas, United States, 75216

Sponsors and Collaborators
  More Information


Study ID Numbers:   430
First Received:   December 29, 2000
Last Updated:   April 20, 2007
ClinicalTrials.gov Identifier:   NCT00007761
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Bipolar Disease Program intervention,bipolar disease  

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on November 20, 2008




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