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

Completed

• Conditions: Schizophrenia; Affective Symptoms

• Registration Number: NCT01534936
• Lead Sponsor: AstraZeneca

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 Description

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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2153

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms.	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 Outcome Measures

Name	Time	Method
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 Raskin Scale.	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.
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	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".

Trial Locations

Locations (1)

Research Site; 🇭🇺 Veszprem, Hungary