Clinical Trial: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.

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 Summary: Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary
Sponsor: AstraZeneca

Current Primary Outcome: Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms. [ Time Frame: 3 and 6 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Description of the relation between and the change of affective symptoms and overall clinical status. [ Time Frame: 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). [ Time Frame: From baseline up to 6 months ]
    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 ]
    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.


Original Secondary Outcome:

  • Description of the relation between and the change of affective symptoms and overall clinical status. [ Time Frame: 3 and 6 months ]
  • 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 ]
    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 ]
    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.


Information By: AstraZeneca

Dates:
Date Received: February 13, 2012
Date Started: February 2012
Date Completion:
Last Updated: December 19, 2012
Last Verified: December 2012