Evaluation of Patients With Rapid Cycling Bipolar Disorder (RCBD)
Primary Purpose
Bipolar Disorder, Rapid Cycling Bipolar Disorder
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Bipolar Disorder focused on measuring Bipolar Disorder, Rapid Cycling, Screening
Eligibility Criteria
Must be currently in treatment with a psychiatrist. Subjects must not have borderline or antisocial personality disorders, must not meet criteria for substance abuse or dependence within the past six months. Subjects must not have significant hepatic, renal, endocrine, or cardiovascular disease. Subjects must not be pregnant.
Sites / Locations
- National Institute of Mental Health (NIMH)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001772
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00001772
Brief Title
Evaluation of Patients With Rapid Cycling Bipolar Disorder (RCBD)
Official Title
Evaluation of Patients With Rapid Cycling Bipolar Disorder
Study Type
Observational
2. Study Status
Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
Bipolar disorder is a mood (affective) disorder characterized by the occurrence of alternating feelings of excitement (mania) and depression. It is a common, but serious condition, and potentially life-threatening. Patients are considered to have a rapid cycling form of bipolar disorder if they experience four or more episodes of hypomania (mild degree of mania), mania, and/or depression. Approximately 20% of the patients in bipolar clinics have the rapid cycling form of the disorder. Therefore it can be said that RCBD is not a rare condition and that it can severely impair a patient. These reasons alone justify studying RCBD. However, researchers also believe that information gathered by studying patients with RCBD can be used while studying other patients with different forms of bipolar disorder.
The purpose of this study is to screen patients diagnosed as having rapid cycling bipolar disorder to see if they fit the criteria for the diagnosis and to see if they would be interested in participating in other research studies.
Patients will undergo diagnostic interviews, physical examination, routine blood tests, EKG (electrocardiogram), and complete self-rating forms as part of the screening process.
Detailed Description
The purpose of this protocol is to allow for the medical and psychiatric screening of patients with rapid cycling bipolar disorder in order to ascertain (1) that they fit the criteria for the diagnosis; and (2) that they are interested in participating in one of our research projects. Patients will undergo diagnostic interviews, complete self-rating forms, and have a physical examination, routine blood tests, and an electrocardiogram.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Rapid Cycling Bipolar Disorder
Keywords
Bipolar Disorder, Rapid Cycling, Screening
7. Study Design
Enrollment
50 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Must be currently in treatment with a psychiatrist.
Subjects must not have borderline or antisocial personality disorders, must not meet criteria for substance abuse or dependence within the past six months.
Subjects must not have significant hepatic, renal, endocrine, or cardiovascular disease.
Subjects must not be pregnant.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
4589148
Citation
Dunner DL, Fieve RR. Clinical factors in lithium carbonate prophylaxis failure. Arch Gen Psychiatry. 1974 Feb;30(2):229-33. doi: 10.1001/archpsyc.1974.01760080077013. No abstract available.
Results Reference
background
PubMed Identifier
1550465
Citation
Coryell W, Endicott J, Keller M. Rapidly cycling affective disorder. Demographics, diagnosis, family history, and course. Arch Gen Psychiatry. 1992 Feb;49(2):126-31. doi: 10.1001/archpsyc.1992.01820020046006.
Results Reference
background
PubMed Identifier
8561195
Citation
Leibenluft E. Women with bipolar illness: clinical and research issues. Am J Psychiatry. 1996 Feb;153(2):163-73. doi: 10.1176/ajp.153.2.163.
Results Reference
background
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Evaluation of Patients With Rapid Cycling Bipolar Disorder (RCBD)
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