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Predictors of Recurrence in Bipolar Disorder in Spain (PREBIS)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690859
First received: June 3, 2008
Last updated: May 28, 2009
Last verified: May 2009
History of Changes
  Purpose

Observational, prospective (1 year follow up), multicenter, non-interventional open label study in order to assess the factors that predict onset of mood disorders episodes (depression, mania, hypomania and mixed) in stabilized patients with bipolar disorder I or II in Spain. Other objectives are

  1. to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality
  2. to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms
  3. to evaluate the economical impact on health service of these patients (hospitalization, primary care, treatments…).

Target population is ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment. The primary endpoint is the onset of mood disorders episodes (depression, mania, hypomania and mixed) during the follow-up period and evaluation of which factors predict onset of mood episodes


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period [ Time Frame: Every three months ]
  • Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed) [ Time Frame: Every three months ]

Secondary Outcome Measures:
  • Evaluation of factors that can predict functional outcomes [ Time Frame: Every three months ]
  • Description of Health services utilization (hospitalisations, primary care, treatments..) [ Time Frame: Every three months ]

Enrollment: 595
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory bipolar I and II patients, clinically stabilized for at least the two months prior to recruitment and who had at least one acute episode (depressive, manic, hypomanic or mixed) within the year prior to recruitment.

Criteria

Inclusion Criteria:

  • Diagnosed of Bipolar Disorder I or II (DSM-IV-TR)
  • Patients Stabilized from at least 2 months who had a mood disorder episode (depression, mania, hypomania or mixed) in the last year.
  • To be attended by a psychiatric specialist

Exclusion Criteria:

  • Inability to participate in the study
  • To have taken part in other study in the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690859

  Show 49 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00690859     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2007/1
Study First Received: June 3, 2008
Last Updated: May 28, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Bipolar disorders
Predictors of recurrence

Additional relevant MeSH terms:
Bipolar Disorder
Recurrence
Affective Disorders, Psychotic
Mood Disorders
 Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013