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

Tracking Information
First Received Date ^ICMJE	December 7, 2010
Last Updated Date	October 25, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01255982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Official Title ^ICMJE	Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Bipolar Disorder Bipolar Depression
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	249
Completion Date	October 2012
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01255982
Other Study ID Numbers ^ICMJE	NIS-NES-DUM-2010/1
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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