Predictors of Recurrence in Bipolar Disorder in Spain

Study Overview
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Brief Summary
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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 to describe the clinical course of illness in a cohort of patients with TB I or II: duration, severity, polarity and seasonality to describe clinical and functional situation of patients during the different phases, evaluating prognostic meaning of subsyndromal symptoms 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

Official Title
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Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

Conditions
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Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of factors that can predict functional outcomes |  | Every three months | 
| Description of Health services utilization (hospitalisations, primary care, treatments..) |  | Every three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar disorders, Predictors of recurrence