Predictors of Recurrence in Bipolar Disorder in Spain

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00690859
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-05
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 595

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

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Exclusion Criteria

• Inability to participate in the study
• To have taken part in other study in the last 6 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period	Every three months
Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)	Every three months

Secondary Outcome Measures

Name	Time	Method
Evaluation of factors that can predict functional outcomes	Every three months
Description of Health services utilization (hospitalisations, primary care, treatments..)	Every three months

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain