Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary (AFFECT)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01534936
First received: February 13, 2012
Last updated: December 19, 2012
Last verified: December 2012
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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.
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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:
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
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Hide Study LocationsLocations
| Hungary | |
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| Agard, Hungary | |
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| Baja, Hungary | |
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| Barcs, Hungary | |
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| Berettyoujfalu, Hungary | |
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| Bicske, Hungary | |
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| Bonyhad, Hungary | |
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| Budapest, Hungary | |
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| Cegled, Hungary | |
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| Debrecen, Hungary | |
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| Dombovar, Hungary | |
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| Dunaujvaros, Hungary | |
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| Erd, Hungary | |
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| Esztergom, Hungary | |
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| Gyongyos, Hungary | |
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| Gyor, Hungary | |
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| Gyula, Hungary | |
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| Hatvan, Hungary | |
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| Heves, Hungary | |
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| Hodmezovasarhely, Hungary | |
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| Izsofalva, Hungary | |
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| Janoshalma, Hungary | |
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| Jaszbereny, Hungary | |
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| Kalocsa, Hungary | |
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| Karcag, Hungary | |
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| Kecskemet, Hungary | |
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| Kiskunhalas, Hungary | |
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| Kiskunmajsa, Hungary | |
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| Kistarcsa, Hungary | |
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| Kistokaj, Hungary | |
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| Mako, Hungary | |
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| Miskolc, Hungary | |
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| Mosonmagyarovar, Hungary | |
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| Nagykallo, Hungary | |
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| Nagykanizsa, Hungary | |
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| Oroszlany, Hungary | |
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| Papa, Hungary | |
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| Pecs, Hungary | |
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| Pomaz, Hungary | |
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| Salgotarjan, Hungary | |
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| Satoraljaujhely, Hungary | |
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| Sopron, Hungary | |
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| Szeged, Hungary | |
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| Szeghalom, Hungary | |
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| Szekesfehervar, Hungary | |
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| Szekszard, Hungary | |
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| Szentendre, Hungary | |
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| Szentes, Hungary | |
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| Szigetszentmiklos, Hungary | |
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| Szolnok, Hungary | |
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| Szombathely, Hungary | |
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| Toszeg, Hungary | |
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| Vac, Hungary | |
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| 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 |
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:
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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 19, 2013