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Depressive Symptoms in Acute Manic Episode

NCT ID: NCT00690248

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Bipolar Disorder

Keywords

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Acute mania Bipolar disorder depressive symptoms mixed mania

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Locations

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Research Site

A Coruña, , Spain

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Alcoy, , Spain

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Algeciras, , Spain

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Almería, , Spain

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Barcelona, , Spain

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Burgos, , Spain

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Córdoba, , Spain

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Granada, , Spain

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Las Palmas, , Spain

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Logroño, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Murcia, , Spain

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Osuna, , Spain

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Oviedo, , Spain

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Palma de Mallorca, , Spain

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Pamplona, , Spain

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Plasencia, , Spain

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Ponferrada, , Spain

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Pontevedra, , Spain

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Salamanca, , Spain

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San Juan (Alicante), , Spain

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Sant Boi de Llobregat, , Spain

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Santa Cruz de Tenerife, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Teruel, , Spain

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Toledo, , Spain

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Valencia, , Spain

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Valladolid, , Spain

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Vitoria-Gasteiz, , Spain

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Zamora, , Spain

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Zaragoza, , Spain

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Countries

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Spain

Other Identifiers

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NIS-NES-DUM-2007/5

Identifier Type: -

Identifier Source: org_study_id