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Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255982
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):

Brief Summary:
This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.

Condition or disease
Bipolar Disorder Bipolar Depression

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Study Type : Observational
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Study Start Date : March 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion

Primary Outcome Measures :
  1. Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change [ Time Frame: Range of Days 0-3 ]

Secondary Outcome Measures :
  1. FAST score to estimate the proportion of patients that not achieve functional remission [ Time Frame: Range of Days 0-3 ]
  2. Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission [ Time Frame: Range of Days 0-3 ]
  3. Mood chart (self-report) [ Time Frame: Range of Days 0-3 ]
  4. The presence of subsyndromal symptoms after the acute depressive phase using Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR) [ Time Frame: Range of Days 0-3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or II disorder experiencing an acute depressive episode.

Inclusion Criteria:

  • Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
  • Acute depressive episode at inclusion

Exclusion Criteria:

  • Inability (in investigator´s opinion) to carry out the follow-up plan
  • Patients participating or having participated within previous 6 months, in clinical trials
  • Mental retardation or any other medical condition affecting cognitive performance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255982

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Research Site
Elche, Alicante, Spain
Research Site
Villajoyosa, Alicante, Spain
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Sama de Langreo, Asturias, Spain
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Granollers, Barcelona, Spain
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San Boit de LLobregat, Barcelona, Spain
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Monforte de Lemos, Lugo, Spain
Research Site
Tudela, Navarra, Spain
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Mos, Pontevedra, Spain
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Catarroja, Valencia, Spain
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Almería, Spain
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Barcelona, Spain
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Cordoba, Spain
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Granada, Spain
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Lerida, Spain
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Madrid, Spain
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Malaga, Spain
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Orense, Spain
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Palencia, Spain
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Palma de Mallorca, Spain
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Sevilla, Spain
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Tarragona, Spain
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Valencia, Spain
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Zamora, Spain
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Zaragoza, Spain
Sponsors and Collaborators
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Responsible Party: AstraZeneca Identifier: NCT01255982    
Other Study ID Numbers: NIS-NES-DUM-2010/1
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
Bipolar depression
subsyndromal symptoms
cognitive function
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders