AFFECT: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Schizophrenic outpatients with affective symptoms.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Agard | Hungary | ||
| 2 | Research Site | Baja | Hungary | ||
| 3 | Research Site | Barcs | Hungary | ||
| 4 | Research Site | Berettyoujfalu | Hungary | ||
| 5 | Research Site | Bicske | Hungary | ||
| 6 | Research Site | Bonyhad | Hungary | ||
| 7 | Research Site | Budapest | Hungary | ||
| 8 | Research Site | Cegled | Hungary | ||
| 9 | Research Site | Debrecen | Hungary | ||
| 10 | Research Site | Dombovar | Hungary | ||
| 11 | Research Site | Dunaujvaros | Hungary | ||
| 12 | Research Site | Erd | Hungary | ||
| 13 | Research Site | Esztergom | Hungary | ||
| 14 | Research Site | Gyongyos | Hungary | ||
| 15 | Research Site | Gyor | Hungary | ||
| 16 | Research Site | Gyula | Hungary | ||
| 17 | Research Site | Hatvan | Hungary | ||
| 18 | Research Site | Heves | Hungary | ||
| 19 | Research Site | Hodmezovasarhely | Hungary | ||
| 20 | Research Site | Izsofalva | Hungary | ||
| 21 | Research Site | Janoshalma | Hungary | ||
| 22 | Research Site | Jaszbereny | Hungary | ||
| 23 | Research Site | Kalocsa | Hungary | ||
| 24 | Research Site | Karcag | Hungary | ||
| 25 | Research Site | Kecskemet | Hungary | ||
| 26 | Research Site | Kiskunhalas | Hungary | ||
| 27 | Research Site | Kiskunmajsa | Hungary | ||
| 28 | Research Site | Kistarcsa | Hungary | ||
| 29 | Research Site | Kistokaj | Hungary | ||
| 30 | Research Site | Mako | Hungary | ||
| 31 | Research Site | Miskolc | Hungary | ||
| 32 | Research Site | Mosonmagyarovar | Hungary | ||
| 33 | Research Site | Nagykallo | Hungary | ||
| 34 | Research Site | Nagykanizsa | Hungary | ||
| 35 | Research Site | Oroszlany | Hungary | ||
| 36 | Research Site | Papa | Hungary | ||
| 37 | Research Site | Pecs | Hungary | ||
| 38 | Research Site | Pomaz | Hungary | ||
| 39 | Research Site | Salgotarjan | Hungary | ||
| 40 | Research Site | Satoraljaujhely | Hungary | ||
| 41 | Research Site | Sopron | Hungary | ||
| 42 | Research Site | Szeged | Hungary | ||
| 43 | Research Site | Szeghalom | Hungary | ||
| 44 | Research Site | Szekesfehervar | Hungary | ||
| 45 | Research Site | Szekszard | Hungary | ||
| 46 | Research Site | Szentendre | Hungary | ||
| 47 | Research Site | Szentes | Hungary | ||
| 48 | Research Site | Szigetszentmiklos | Hungary | ||
| 49 | Research Site | Szolnok | Hungary | ||
| 50 | Research Site | Szombathely | Hungary | ||
| 51 | Research Site | Toszeg | Hungary | ||
| 52 | Research Site | Vac | Hungary | ||
| 53 | Research Site | Veszprem | Hungary |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIS-NHU-ATC-2011/1