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Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. Clinical research trials and Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms.. Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. clinical trial. Human subjects often get the best healthcare possible for their Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms. condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms.  Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms.
Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms.
For Condition: Bipolar Disorder
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 382
Location and Contact Information:
Vamc - Mountain Home, Tn
Mountain Home, Tennessee, 37684
United States
Vamc - Denver, Co
Denver, Colorado, 80220
United States
Vamc - Cleveland (Wade Park/Brecksville)
Brecksville, Ohio, 44141
United States
Vamc - San Diego, Ca
San Diego, California, 92161
United States
Vamc - West Los Angeles, Los Angeles, Ca
Los Angeles, California, 90073
United States
Vamc - Dallas, Tx
Dallas, Texas, 75216
United States
Vamc - Edward Hines, Jr. Hine, Il
Hines, Illinois, 60141
United States
Vamc - Tucson, Az
Tucson, Arizona, 85723
United States
Vamc - Palo Alto, Ca
Palo Alto, California, 94304
United States
Vamc - Augusta, Ga
Augusta, Georgia, 30904
United States
Vamc - Richard L. Roudebush, in
Indianapolis, Indiana, 46202
United States
Vamc - West Haven, Ct
West Haven, Connecticut, 06516
United States
Additional Information:
Study ID Numbers: 430;
Study Start Date: July 1997
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007761
Other Bipolar Disorder Studies:
1. Clozapine vs. Placebo in Treatment-Refractory Bipolar Disorder in Children and Adolescents
2. A Study of the Safety and Efficacy of Topiramate in the Treatment of Patients with Bipolar I Disorder
3. Effects of Sex Hormones on Circadian Rhythm in Men and Women
4. Evaluation of Patients with Rapid Cycling Bipolar Disorder (RCBD)
5. Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders
Related Studies:
Other Bipolar Disorder Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Does Bipolar Disease Program (BDP) intervention improve long term manic and depressive symptoms.
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