Schizophrenia Clinical Trial
— AFFECTOfficial title:
Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.
Verified date | December 2012 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2153 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Hungary | Research Site | Agard | |
Hungary | Research Site | Baja | |
Hungary | Research Site | Barcs | |
Hungary | Research Site | Berettyoujfalu | |
Hungary | Research Site | Bicske | |
Hungary | Research Site | Bonyhad | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Cegled | |
Hungary | Research Site | Debrecen | |
Hungary | Research Site | Dombovar | |
Hungary | Research Site | Dunaujvaros | |
Hungary | Research Site | Erd | |
Hungary | Research Site | Esztergom | |
Hungary | Research Site | Gyongyos | |
Hungary | Research Site | Gyor | |
Hungary | Research Site | Gyula | |
Hungary | Research Site | Hatvan | |
Hungary | Research Site | Heves | |
Hungary | Research Site | Hodmezovasarhely | |
Hungary | Research Site | Izsofalva | |
Hungary | Research Site | Janoshalma | |
Hungary | Research Site | Jaszbereny | |
Hungary | Research Site | Kalocsa | |
Hungary | Research Site | Karcag | |
Hungary | Research Site | Kecskemet | |
Hungary | Research Site | Kiskunhalas | |
Hungary | Research Site | Kiskunmajsa | |
Hungary | Research Site | Kistarcsa | |
Hungary | Research Site | Kistokaj | |
Hungary | Research Site | Mako | |
Hungary | Research Site | Miskolc | |
Hungary | Research Site | Mosonmagyarovar | |
Hungary | Research Site | Nagykallo | |
Hungary | Research Site | Nagykanizsa | |
Hungary | Research Site | Oroszlany | |
Hungary | Research Site | Papa | |
Hungary | Research Site | Pecs | |
Hungary | Research Site | Pomaz | |
Hungary | Research Site | Salgotarjan | |
Hungary | Research Site | Satoraljaujhely | |
Hungary | Research Site | Sopron | |
Hungary | Research Site | Szeged | |
Hungary | Research Site | Szeghalom | |
Hungary | Research Site | Szekesfehervar | |
Hungary | Research Site | Szekszard | |
Hungary | Research Site | Szentendre | |
Hungary | Research Site | Szentes | |
Hungary | Research Site | Szigetszentmiklos | |
Hungary | Research Site | Szolnok | |
Hungary | Research Site | Szombathely | |
Hungary | Research Site | Toszeg | |
Hungary | Research Site | Vac | |
Hungary | Research Site | Veszprem |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Description of the relation between and the change of affective symptoms and overall clinical status. | 3 and 6 months | No | |
Secondary | 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 | No |
Secondary | 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 | No |
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