Status:
COMPLETED
Depressive Symptoms in Acute Manic Episode
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
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 admitte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00690248
Start Date
November 1 2007
End Date
December 1 2008
Last Update
December 9 2010
Active Locations (34)
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1
Research Site
A Coruña, Spain
2
Research Site
Alcoy, Spain
3
Research Site
Algeciras, Spain
4
Research Site
Almería, Spain