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Predictors of Recurrence in Bipolar Disorder in Spain

NCT00690859 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 595

Last updated 2020-01-22

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00690859 on ClinicalTrials.gov