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

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ClinicalTrials.gov Identifier: NCT01255982
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

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
Primary Completion Date : December 2011
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
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 ]


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01255982


Locations
Spain
Research Site
Elche, Alicante, Spain
Research Site
Villajoyosa, Alicante, Spain
Research Site
Sama de Langreo, Asturias, Spain
Research Site
Granollers, Barcelona, Spain
Research Site
San Boit de LLobregat, Barcelona, Spain
Research Site
Monforte de Lemos, Lugo, Spain
Research Site
Tudela, Navarra, Spain
Research Site
Mos, Pontevedra, Spain
Research Site
Catarroja, Valencia, Spain
Research Site
Almería, Spain
Research Site
Barcelona, Spain
Research Site
Cordoba, Spain
Research Site
Granada, Spain
Research Site
Lerida, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Orense, Spain
Research Site
Palencia, Spain
Research Site
Palma de Mallorca, Spain
Research Site
Sevilla, Spain
Research Site
Tarragona, Spain
Research Site
Valencia, Spain
Research Site
Zamora, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01255982     History of Changes
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
functioning
cognitive function

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders