Depressive Symptoms in Acute Manic Episode
MM1
Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study
1 other identifier
observational
250
1 country
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2007
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 9, 2010
December 1, 2010
8 months
June 2, 2008
December 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.
once during study
Secondary Outcomes (7)
Mania symptoms measured with YMRS (Young Mania Rating Scale).
once during study
Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).
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
Days of hospitalization, MADRS (6 items)
once during study
- +2 more secondary outcomes
Study Arms (1)
1
Bipolar patients admitted to a psychiatric Unit due to an acute mania episode.
Eligibility Criteria
bipolar patients admitted to a psychiatric Unit due to an acute mania episode.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 4, 2008
Study Start
November 1, 2007
Primary Completion
July 1, 2008
Study Completion
December 1, 2008
Last Updated
December 9, 2010
Record last verified: 2010-12