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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

December 7, 2010
October 25, 2012
March 2011
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01255982 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or II disorder experiencing an acute depressive episode.

  • Bipolar Disorder
  • Bipolar Depression
Not Provided
1
Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
October 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01255982
NIS-NES-DUM-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP