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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255982
• Other study ID #: NIS-NES-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: October 25, 2012
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Spain	Research Site	Almería
Spain	Research Site	Barcelona
Spain	Research Site	Catarroja	Valencia
Spain	Research Site	Cordoba
Spain	Research Site	Elche	Alicante
Spain	Research Site	Granada
Spain	Research Site	Granollers	Barcelona
Spain	Research Site	Lerida
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Monforte de Lemos	Lugo
Spain	Research Site	Mos	Pontevedra
Spain	Research Site	Orense
Spain	Research Site	Palencia
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Sama de Langreo	Asturias
Spain	Research Site	San Boit de LLobregat	Barcelona
Spain	Research Site	Sevilla
Spain	Research Site	Tarragona
Spain	Research Site	Tudela	Navarra
Spain	Research Site	Valencia
Spain	Research Site	Villajoyosa	Alicante
Spain	Research Site	Zamora
Spain	Research Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change		Range of Days 0-3	No
Secondary	FAST score to estimate the proportion of patients that not achieve functional remission		Range of Days 0-3	No
Secondary	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	No
Secondary	Mood chart (self-report)		Range of Days 0-3	No
Secondary	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	No