Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
1 other identifier
observational
249
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 26, 2012
October 1, 2012
9 months
December 7, 2010
October 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
Range of Days 0-3
Secondary Outcomes (4)
FAST score to estimate the proportion of patients that not achieve functional remission
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
Range of Days 0-3
Mood chart (self-report)
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)
Range of Days 0-3
Study Arms (1)
1
Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion
Eligibility Criteria
Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or II disorder experiencing an acute depressive episode.
You may qualify if:
- Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Elche, Alicante, Spain
Research Site
Villajoyosa, Alicante, Spain
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Almería, Almería, Spain
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Barcelona, Barcelona, Spain
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Granollers, Barcelona, Spain
Research Site
San Boit de LLobregat, Barcelona, Spain
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Córdoba, Cordoba, Spain
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Granada, Granada, Spain
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Lleida, Lerida, Spain
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Monforte de Lemos, Lugo, Spain
Research Site
Madrid, Madrid, Spain
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Málaga, Malaga, Spain
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Tudela, Navarre, Spain
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Ourense, Orense, Spain
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Palencia, Palencia, Spain
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Palma de Mallorca, Palma de Mallorca, Spain
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Mos, Pontevedra, Spain
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Langreo, Principality of Asturias, Spain
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Seville, Sevilla, Spain
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Tarragona, Tarragona, Spain
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Catarroja, Valencia, Spain
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Valencia, Valencia, Spain
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Zamora, Zamora, Spain
Research Site
Zaragoza, Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2010
First Posted
December 8, 2010
Study Start
March 1, 2011
Primary Completion
December 1, 2011
Study Completion
October 1, 2012
Last Updated
October 26, 2012
Record last verified: 2012-10