Depressive Symptoms in Acute Manic Episode

Bipolar Disorder Clinical Trial

— MM1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690248
• Other study ID #: NIS-NES-DUM-2007/5
• Status: Completed
• Phase: N/A
• First received: June 2, 2008
• Last updated: December 7, 2010
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: NA
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed of Bipolar Disorder based on DSM-IV-TR

• Patients admitted to an acute inpatient psychiatric Unit due to an acute manic episode (as defined in DSM-IV_TR)

• Provision of written informed consent.

• Total score in Young Mania Rating Scale >=20

• Able to understand and comply with the requirements of the study

Exclusion Criteria:

• Mental retardation

• Patients with manic symptoms are due to substance use, based in the investigator opinion

• Patients with unstable organic diseases, who are not receiving adequate treatment, according the investigator opinion.

• Participation in a trial with drugs within 4 weeks of enrolment into this study.

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Spain	Research Site	Alcoy
Spain	Research Site	Algeciras
Spain	Research Site	Almeria
Spain	Research Site	Barcelona
Spain	Research Site	Burgos
Spain	Research Site	Cordoba
Spain	Research Site	Granada
Spain	Research Site	La Coruna
Spain	Research Site	Las Palmas
Spain	Research Site	Logrono
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Murcia
Spain	Research Site	Osuna
Spain	Research Site	Oviedo
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Pamplona
Spain	Research Site	Plasencia
Spain	Research Site	Ponferrada
Spain	Research Site	Pontevedra
Spain	Research Site	Salamanca
Spain	Research Site	San Juan (Alicante)
Spain	Research Site	Sant Boi de Llobregat
Spain	Research Site	Santander
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Sevilla
Spain	Research Site	Tenerife
Spain	Research Site	Teruel
Spain	Research Site	Toledo
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Spain	Research Site	Vitoria
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	Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.		once during study	No
Secondary	Mania symptoms measured with YMRS (Young Mania Rating Scale).		once during study	No
Secondary	Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).		once during study	No
Secondary	Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).		once during study	No
Secondary	Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).		once during study	No
Secondary	Days of hospitalization, MADRS (6 items)		once during study	No
Secondary	Hamilton Depression Rating Scale (5 items)		once during study	No
Secondary	Scale of Unawareness of Mental Disorders (SUMD)		once during study	No