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Predictors of Recurrence in Bipolar Disorder in Spain — PREBIS  

Bipolar Disorder Clinical Trial

Official title:
Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00690859
Study type Observational
Source AstraZeneca
Contact
Status Completed
Phase
Start date June 2007
Completion date March 2009
View Details
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