Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients

Bipolar Disorder Clinical Trial

Official title:

Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992302
• Other study ID #: RC-BBP
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: November 18, 2013
• Start date: June 2004
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Major medical comorbidities, voluntary drop-out from study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Spain	Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who develop rapid cycling		8 years	Yes
Secondary	Factors associated with the development of a rapid cycling course in bipolar disorder patients		8 years	Yes