Depressive Symptoms in Acute Manic Episode

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00690248
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-04
• Primary Completion: 2008-07
• Study Completion: 2008-12
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.	once during study

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).	once during study
Hamilton Depression Rating Scale (5 items)	once during study
Mania symptoms measured with YMRS (Young Mania Rating Scale).	once during study
Scale of Unawareness of Mental Disorders (SUMD)	once during study
Days of hospitalization, MADRS (6 items)	once during study
Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).	once during study
Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).	once during study

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain