Clinical trial NCT00001772: Evaluation of Patients With Rapid Cycling Bipolar Disorder (RCBD)
Official title: Evaluation of Patients With Rapid Cycling Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Rapid Cycling Bipolar Disorder
Keywords: Bipolar Disorder
Rapid Cycling
Screening
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Mental Health (NIMH)
state: Maryland
Study officials:
References:
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.
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.
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.