Affective Symptoms, Schizophrenia
Conditions
Keywords
schizophrenia, atypical antipsychotics, depressive symptoms
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
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
Hungary
Outcome results
None listed