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

October 25, 2012 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • 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
        • Research Site
    • Alicante
      • Elche, Alicante, Spain
        • Research Site
      • Villajoyosa, Alicante, Spain
        • Research Site
    • Asturias
      • Sama de Langreo, Asturias, Spain
        • Research Site
    • Barcelona
      • Granollers, Barcelona, Spain
        • Research Site
      • San Boit de LLobregat, Barcelona, Spain
        • Research Site
    • Lugo
      • Monforte de Lemos, Lugo, Spain
        • Research Site
    • Navarra
      • Tudela, Navarra, Spain
        • Research Site
    • Pontevedra
      • Mos, Pontevedra, Spain
        • Research Site
    • Valencia
      • Catarroja, Valencia, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
Time Frame: Range of Days 0-3
Range of Days 0-3

Secondary Outcome Measures

Outcome Measure
Time Frame
FAST score to estimate the proportion of patients that not achieve functional remission
Time Frame: Range of Days 0-3
Range of Days 0-3
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
Range of Days 0-3
Mood chart (self-report)
Time Frame: Range of Days 0-3
Range of Days 0-3
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
Range of Days 0-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (Estimate)

December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NES-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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