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

Schizophrenia Clinical Trial

— AFFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534936
• Other study ID #: NIS-NHU-ATC-2011/1
• 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

• Affective Symptoms
• Schizophrenia

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