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Completed

NCT Number: NCT01534936

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.

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Key information

Conditions

Schizophrenia Affective Symptoms Behavior Behavioral Symptoms Depression Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Agárd, Hungary

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About this study

Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Description of the relation between and the change of affective symptoms and overall clinical status.

    Time frame: 3 and 6 months

  2. 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".

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: AFFECT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2012
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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