Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 6, 2013
First Posted Date November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date June 2004
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2013)
Number of patients who develop rapid cycling [ Time Frame: 8 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 18, 2013)
Factors associated with the development of a rapid cycling course in bipolar disorder patients [ Time Frame: 8 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
Official Title Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Bipolar I and II disorder patients
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2013)
289
Original Actual Enrollment Same as current
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major medical comorbidities, voluntary drop-out from study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01992302
Other Study ID Numbers RC-BBP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marc Valenti, Hospital Clinic of Barcelona
Study Sponsor Hospital Clinic of Barcelona
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date November 2013