Clinical trial NCT01534936: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary
Official title: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Affective Symptoms
Keywords: schizophrenia
atypical antipsychotics
depressive symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 2153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Schizophrenic outpatients above 18 years of age with affective symptoms.

Brief 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.

Detailed description: Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms.
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Description of the relation between and the change of affective symptoms and overall clinical status.
timeFrame: 3 and 6 months
measure: 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).
timeFrame: From baseline up to 6 months
measure: Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale.
timeFrame: From baseline up to 6 months
Other outcomes:
Locations:
city: Agard
country: Hungary
facility: Research Site
city: Baja
country: Hungary
facility: Research Site
city: Barcs
country: Hungary
facility: Research Site
city: Berettyoujfalu
country: Hungary
facility: Research Site
city: Bicske
country: Hungary
facility: Research Site
city: Bonyhad
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Dombovar
country: Hungary
facility: Research Site
city: Dunaujvaros
country: Hungary
facility: Research Site
city: Erd
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Gyongyos
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Hatvan
country: Hungary
facility: Research Site
city: Heves
country: Hungary
facility: Research Site
city: Hodmezovasarhely
country: Hungary
facility: Research Site
city: Izsofalva
country: Hungary
facility: Research Site
city: Janoshalma
country: Hungary
facility: Research Site
city: Jaszbereny
country: Hungary
facility: Research Site
city: Kalocsa
country: Hungary
facility: Research Site
city: Karcag
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Kiskunhalas
country: Hungary
facility: Research Site
city: Kiskunmajsa
country: Hungary
facility: Research Site
city: Kistarcsa
country: Hungary
facility: Research Site
city: Kistokaj
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Nagykallo
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Oroszlany
country: Hungary
facility: Research Site
city: Papa
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Pomaz
country: Hungary
facility: Research Site
city: Salgotarjan
country: Hungary
facility: Research Site
city: Satoraljaujhely
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szeghalom
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szekszard
country: Hungary
facility: Research Site
city: Szentendre
country: Hungary
facility: Research Site
city: Szentes
country: Hungary
facility: Research Site
city: Szigetszentmiklos
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Toszeg
country: Hungary
facility: Research Site
city: Vac
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
Study officials:
affiliation: National Center of Psychiatry
name: Attila Nemeth, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Lilla Szabo, MD
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Alexandra Heringh, MD
role: STUDY_DIRECTOR
References: