- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992302
Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
November 18, 2013 updated by: Marc Valenti, Hospital Clinic of Barcelona
In this study we tried to elucidate the factors associated with the development of a rapid cycling course in bipolar disorder patients, in a prospective and longitudinal design, and the role of antidepressants.
The identification of risk factors is extremely relevant from the clinical point of view.
We hypothesized that rapid cycling bipolar disorder is associated with more chronicity, poor outcome, and more antidepressant prescription.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
289
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Catalonia
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Barcelona, Catalonia, Spain, 08037
- Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Bipolar I and II disorder patients
Description
Inclusion Criteria:
- Bipolar I and II disorder patients according to DSM-IV criteria
Exclusion Criteria:
- Major medical comorbidities, voluntary drop-out from study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rapid Cycling Group
Patients who develop a rapid cycling course during the follow-up period.
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Non Rapid Cycling Group
Patients who do not develop a rapid cycling course during the follow-up period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who develop rapid cycling
Time Frame: 8 years
|
8 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Factors associated with the development of a rapid cycling course in bipolar disorder patients
Time Frame: 8 years
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
November 6, 2013
First Submitted That Met QC Criteria
November 18, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-BBP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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