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.

Completed

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Key information

Conditions

Bipolar Disorder Bipolar Depression Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Elche, Alicante, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change

Time frame: Range of Days 0-3

Secondary outcomes

FAST score to estimate the proportion of patients that not achieve functional remission

Time frame: 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
Mood chart (self-report)

Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Dec 8, 2010
Registry last updated: Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed