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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01534936
Other study ID # NIS-NHU-ATC-2011/1
Secondary ID
Status Completed
Phase N/A
First received February 13, 2012
Last updated December 19, 2012
Start date February 2012
Est. completion date December 2012

Study information

Verified date December 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Hungary, 

Outcome

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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