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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
  Purpose

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.


Condition
Schizophrenia
Affective Symptoms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2153
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Schizophrenic outpatients with affective symptoms.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Schizophrenic outpatients above 18 years of age with affective symptoms.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534936

  Show 53 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Attila Nemeth, MD PHD National Center of Psychiatry
Study Chair: Lilla Szabo, MD AstraZeneca
Study Director: Alexandra Heringh, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01534936     History of Changes
Other Study ID Numbers: NIS-NHU-ATC-2011/1
Study First Received: February 13, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
schizophrenia
atypical antipsychotics
depressive symptoms

Additional relevant MeSH terms:
Affective Symptoms
Schizophrenia
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013