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Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary (AFFECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01534936
First received: February 13, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes

February 13, 2012
December 19, 2012
February 2012
December 2012   (final data collection date for primary outcome measure)
Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01534936 on ClinicalTrials.gov Archive Site
  • Description of the relation between and the change of affective symptoms and overall clinical status. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
    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".
  • Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale. [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
    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.
  • Description of the relation between and the change of affective symptoms and overall clinical status. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Assesement 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). [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
    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".
  • Assesement of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale. [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary
Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.

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.

Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Schizophrenic outpatients above 18 years of age with affective symptoms.
  • Schizophrenia
  • Affective Symptoms
Not Provided
Schizophrenic outpatients with affective symptoms.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2153
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01534936
NIS-NHU-ATC-2011/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Attila Nemeth, MD PHD National Center of Psychiatry
Study Chair: Lilla Szabo, MD AstraZeneca
Study Director: Alexandra Heringh, MD AstraZeneca
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP