Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary

Study Overview
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Brief Summary
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This is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics.

Detailed Description
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Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary

Official Title
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Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.

Conditions
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Schizophrenia, Affective Symptoms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenic outpatients diagnosis based on DSM -IV above 18 years of age with affective symptoms. Atypical antipsychotic treatment at least for a month before study inclusion. Exclusion Criteria: Pregnancy. Hepatic disease. Diabetes mellitus. Severe cerebro- or cardiovascular disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Schizophrenic outpatients with affective symptoms.<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms. | The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI severity of illness measure (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The CGI global improvement measure (CGI-I) is rated from 1 (very much improved) to 7 (very much worse). 0 stands for not assessed. Means and standard deviations (SD) for CGI-S(baseline), CGI-S (1.visit) CGI-S (2.visit) and for CGI-I will be calculated. | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the relation between and the change of affective symptoms and overall clinical status. |  | 3 and 6 months | 
| Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in CGI-S (CGI severity of illness measure) and CGI-I (CGI global improvement measure). | The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI severity of illness measure (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The CGI global improvement measure (CGI-I) is rated from 1 (very much improved) to 7 (very much worse). 0 stands for not assessed. | From baseline up to 6 months | 
| Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale. | Raskin scale is rated from 1 not at all to 5 very much , in three aspects: verbal report, behaviour, secondary symptoms of depression. Above 9 (the sum points) is considered moderate depression. | From baseline up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, atypical antipsychotics, depressive symptoms