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Completed

NCT Number: NCT00690859

Predictors of Recurrence in Bipolar Disorder in Spain

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

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Victoria, Alava, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Onset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up period

    Time frame: Every three months

  2. Evaluation of the factors that predict onset of mood episodes (depression, mania, hypomania and mixed)

    Time frame: Every three months

Secondary outcomes

  1. Evaluation of factors that can predict functional outcomes

    Time frame: Every three months

  2. Description of Health services utilization (hospitalisations, primary care, treatments..)

    Time frame: Every three months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Evaluation of Predictor Factors of Recurrence in Bipolar Disorder in Spain

Acronym: PREBIS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2008
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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