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NCT01028196 Clinical Trial

Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression

Schizophrenia Clinical Trial

Official title:
Epidemiological Observational Non-interventional Study to Research the Prevalence of Bipolar Criteria of Hospital In-patients With Schizophrenia and Patients With Recurrent Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01028196
Other study ID # NIS-NRU-DUM-2009/1
Secondary ID
Status Completed
Phase N/A
First received December 7, 2009
Last updated October 31, 2011
Start date November 2009
Est. completion date November 2010

Study information
Verified date October 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Observational

Clinical Trial Summary

This study is aimed to evaluate the bipolar disorder symptoms in patients presented with schizophrenia, schizoaffective disorder or recurrent depression.

Bipolar disorder is a group of mood disorders characterised by elevated or irritable mood episodes in patient's lifetime history accompanied by some additional symptoms. In this study modern bipolar disorders screening/assessment instruments will be used to explore the prevalence of bipolarity symptoms in patients who never been diagnosed with bipolar disorders. The results of this study could be useful for more accurate assessment of bipolar disorders prevalence in psychiatric patient population, could help to improve the diagnostics of bipolar disorders and management of bipolar patients.

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- signed patient informed consent

- In-patients with the diagnosis of schizophrenia with episodic course or schizoaffective disorder, OR in-patients and out-patients with the diagnosis of recurrent depression.

- The duration of the disease is 3 years and longer and two or more episodes of the disease in the patients history.

Exclusion Criteria:

- Current diagnosis of Bipolar Disorder

- Severe and unspecified forms of schizophrenia (schizophrenia with continuous course, hebephrenic schizophrenia, catatonic schizophrenia, undifferentiated schizophrenia, unspecified schizophrenia) and organic affective disorder or intoxication induced affective disorder.

- Any other concomitant conditions which, in the judgment of investigator, will not allow the patient to complete the study procedures

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Research Site Chita
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

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