Bipolar DisorderNCT00001772
Evaluation of Patients With Rapid Cycling Bipolar Disorder (RCBD)
An observational study of Bipolar Disorder and Rapid Cycling Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder, Rapid Cycling Bipolar Disorder
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Jul 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Patients With Rapid Cycling Bipolar Disorder
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.
Read the 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.
- Conditions
- Bipolar Disorder, Rapid Cycling Bipolar Disorder
- Keywords
- Bipolar Disorder, Rapid Cycling, Screening
- Medical subject headings
- Bipolar Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startSep 1998
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001772
- Sponsor's protocol ID
- 980156
- Other IDs
- 98-M-0156
- Status last verified
- Aug 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 4589148Coryell 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.
PubMed 1550465Leibenluft 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.
PubMed 8561195
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Rapid Cycling Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00001772
- Acronym / sponsor ID
- 980156
- Conditions
- Bipolar Disorder, Rapid Cycling Bipolar Disorder
- Keywords
- Bipolar Disorder, Rapid Cycling, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Sep 1998
- Study completion
- Jul 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 4589148Dunner 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.
- Background: PubMed 1550465Coryell 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.
- Background: PubMed 8561195Leibenluft 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.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Rapid Cycling Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.