Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01255982
First received: December 7, 2010
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Bipolar Disorder
Bipolar Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change [ Time Frame: Range of Days 0-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FAST score to estimate the proportion of patients that not achieve functional remission [ Time Frame: Range of Days 0-3 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mood chart (self-report) [ Time Frame: Range of Days 0-3 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01255982     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2010/1
Study First Received: December 7, 2010
Last Updated: October 25, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Bipolar depression
subsyndromal symptoms
functioning
cognitive function

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013