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Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients

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ClinicalTrials.gov Identifier: NCT01992302
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Marc Valenti, Hospital Clinic of Barcelona

Brief Summary:
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.

Condition or disease
Bipolar Disorder

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Study Type : Observational
Actual Enrollment : 289 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
Study Start Date : June 2004
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort
Rapid Cycling Group
Patients who develop a rapid cycling course during the follow-up period.
Non Rapid Cycling Group
Patients who do not develop a rapid cycling course during the follow-up period.



Primary Outcome Measures :
  1. Number of patients who develop rapid cycling [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. Factors associated with the development of a rapid cycling course in bipolar disorder patients [ Time Frame: 8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bipolar I and II disorder patients
Criteria

Inclusion Criteria:

  • Bipolar I and II disorder patients according to DSM-IV criteria

Exclusion Criteria:

  • Major medical comorbidities, voluntary drop-out from study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992302


Locations
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Spain
Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08037
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Responsible Party: Marc Valenti, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01992302    
Other Study ID Numbers: RC-BBP
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Marc Valenti, Hospital Clinic of Barcelona:
Rapid cycling
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders