NCT00001772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1998

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Bipolar DisorderRapid Cycling Bipolar Disorder

Keywords

Bipolar DisorderRapid CyclingScreening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 4589148BACKGROUND

  • 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.

    PMID: 1550465BACKGROUND

  • 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.

    PMID: 8561195BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

September 1, 1998

Study Completion

July 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-08

Locations

US(1)