Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 595
- Locations
- 1
- Primary Endpoint
- Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period
Study Overview
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
- 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Evaluation of factors that can predict functional outcomes(Every three months)
- Description of Health services utilization (hospitalisations, primary care, treatments..)(Every three months)