Depressive Symptoms in Acute Manic Episode (MM1)

AstraZeneca

Status: Completed

Conditions: Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT00690248

NIS-NES-DUM-2007/5

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

1

Description:

Bipolar patients admitted to a psychiatric Unit due to an acute mania episode.