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

NCT01534936 | Completed

• 1 other identifier: NIS-NHU-ATC-2011/1
• Study Type: observational
• Target: 2,153
• Locations: 1 country
• Sites: 53

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.

Conditions

Schizophrenia; Affective Symptoms

Keywords

schizophrenia; atypical antipsychotics; depressive symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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).

  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.

  From baseline up to 6 months

Study Arms (1)

Schizophrenic outpatients with affective symptoms.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Schizophrenic outpatients above 18 years of age with affective symptoms.

You may qualify if:

• Schizophrenic outpatients diagnosis based on DSM -IV above 18 years of age with affective symptoms.

You may not qualify if:

• Pregnancy.
• Hepatic disease.
• Diabetes mellitus.
• Severe cerebro- or cardiovascular disease.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (53)

Research Site

Agárd, Hungary

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Baja, Hungary

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Barcs, Hungary

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Berettyóújfalu, Hungary

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Bicske, Hungary

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Bonyhád, Hungary

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Budapest, Hungary

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Cegléd, Hungary

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Debrecen, Hungary

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Dombóvár, Hungary

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Dunaújváros, Hungary

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Esztergom, Hungary

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Érd, Hungary

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Gyöngyös, Hungary

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Győr, Hungary

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Gyula, Hungary

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Hatvan, Hungary

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Heves, Hungary

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Hódmezővásárhely, Hungary

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Izsófalva, Hungary

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Jánoshalma, Hungary

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Jászberény, Hungary

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Kalocsa, Hungary

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Karcag, Hungary

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Kecskemét, Hungary

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Kiskunhalas, Hungary

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Kiskunmajsa, Hungary

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Kistarcsa, Hungary

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Kistokaj, Hungary

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Makó, Hungary

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Miskolc, Hungary

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Mosonmagyaróvár, Hungary

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Nagykanizsa, Hungary

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Nagykálló, Hungary

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Oroszlány, Hungary

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Pápa, Hungary

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Pécs, Hungary

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Pomáz, Hungary

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Salgótarján, Hungary

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Sátoraljaújhely, Hungary

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Sopron, Hungary

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Szeged, Hungary

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Szeghalom, Hungary

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Szekszárd, Hungary

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Szentendre, Hungary

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Szentes, Hungary

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Székesfehérvár, Hungary

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Szigetszentmiklós, Hungary

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Szolnok, Hungary

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Szombathely, Hungary

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Tószeg, Hungary

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Vác, Hungary

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Veszprém, Hungary

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MeSH Terms

Conditions

Schizophrenia; Affective Symptoms; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Attila Nemeth, MD PHD

  National Center of Psychiatry

  PRINCIPAL INVESTIGATOR

• Lilla Szabo, MD

  AstraZeneca

  STUDY CHAIR

• Alexandra Heringh, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 17, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

HU (53)