Depressive Symptoms in Acute Manic Episode — MM1  

Bipolar Disorder Clinical Trial

Official title: Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study

Status Completed

Clinical Trial Summary

Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary objectives include 1) to evaluate, the relationship between depressive symptoms and severity of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the relationship between depressive symptoms and clinical global impression; 6) to evaluate, the relationship between depressive symptoms and previous treatment with antipsychotics (whatever the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the difference on the initial prescription due to the detection of depressive symptoms; 10) to evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bipolar Disorder

• NCT number: NCT00690248
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Completion date: December 2008