Predictors of Recurrence in Bipolar Disorder in Spain

Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00690859

Acronym

PREBIS

Enrollment

595

Registered

2008-06-05

Start date

2007-06-30

Completion date

2009-03-31

Last updated

2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar disorders, Predictors of recurrence

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Spain

Outcome results