Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression
Descriptive Information| Brief Title ICMJE | Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression |
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| Official Title ICMJE | Epidemiological Observational Non-interventional Study to Research the Prevalence of Bipolar Criteria of Hospital In-patients With Schizophrenia and Patients With Recurrent Depression |
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| Brief 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. |
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| Detailed Description | |
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| Study Phase | |
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| Study Type ICMJE | Observational |
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| Study Design ICMJE | Case-Only, Cross-Sectional |
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| Condition ICMJE | - Schizophrenia
- Schizoaffective Disorder
- Recurrent Depression
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| Intervention ICMJE | |
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| Study Arms / Comparison Groups | - 1 - schizophrenia
Psychiatrists will enrol patients meeting inclusion/exclusion criteria with schizophrenia as they routinely attend the clinic or are examined in hospital in a consecutively manner. - 2 - recurrent depression
Psychiatrists will enrol patients meeting inclusion/exclusion criteria with recurrent depression as they routinely attend the clinic or are examined in hospital in a consecutively manner.
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Recruitment Information| Estimated Enrollment ICMJE | 750 |
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| Estimated Completion Date | December 2010 |
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| Primary Completion Date | |
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| Eligibility Criteria ICMJE | 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
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| Gender | Both |
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| Ages | 18 Years to 65 Years |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | |
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| Location Countries ICMJE | Russian Federation |
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Administrative Information| NCT ID ICMJE | NCT01028196 |
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| Responsible Party | MCMD, AstraZeneca |
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| Study ID Numbers ICMJE | NIS-NRU-DUM-2009/1 |
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| Study Sponsor ICMJE | AstraZeneca |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Principal Investigator: | Sergey N. Mosolov, Prof. | Mental Disorders Moscow Research Institute of Psychiatry | |
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| Information Provided By | AstraZeneca |
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