Non-interventional Study: Real-life Use of Atypical Antipsychotics in Acute Inpatient Management of Schizophrenia
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01491412
First received: December 9, 2011
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.
In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.
The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.
| Condition |
|---|
|
Acute Psychotic Episode Schizophrenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Description of used atypical antipsychotic(s) during hospitalisation [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]The data will be collected at one visit at the moment of discharge from the hospital.
- Description of the daily dosage of atypical antipsychotic(s) during hospitalisation [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]The data will be collected at one visit at the moment of discharge from the hospital.
- Description of mode of administration of atypical antipsychotic(s) during hospitalisation [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]The data will be collected at one visit at the moment of discharge from the hospital.
Secondary Outcome Measures:
- Percent of patients with atypical antipsychotic as monotherapy [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
- Percent of patients with combinations of antipsychotics. [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
- Description of main criteria used for selection of an antipsychotic during hospitalisation. [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
- Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment. [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
- Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
- Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
- Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health. [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
| Enrollment: | 503 |
| Study Start Date: | December 2011 |
| Study Completion Date: | May 2012 |
| Groups/Cohorts |
|---|
|
Acute psychotic episode in schizophrenia
Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode
|
Detailed Description:
RECONNECT-S GAMMA : A non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode
Criteria
Inclusion Criteria:
- Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).
- Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- Subject is hospitalised due to an acute psychotic episode
Exclusion Criteria:
- Current participation in any clinical trial.
- Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491412
Locations
| Hungary | |
| Research Site | |
| Budapest, Hungary | |
| Research Site | |
| Debrecen, Hungary | |
| Research Site | |
| Gyor, Hungary | |
| Research Site | |
| Kerepestarcsa, Hungary | |
| Research Site | |
| Nyiregyhaza, Hungary | |
| Research Site | |
| Szekesfehervar, Hungary | |
| Research Site | |
| Szekszard, Hungary | |
| Latvia | |
| Research Site | |
| Daugavpils, Latvia | |
| Research Site | |
| Jelgava, Latvia | |
| Research Site | |
| Liepaja, Latvia | |
| Research Site | |
| Riga, Latvia | |
| Research Site | |
| Strenci, Latvia | |
| Romania | |
| Research Site | |
| Bucharest, Romania | |
| Research Site | |
| Iasi, Romania | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Radu TEODORESCU, Prof. | Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01491412 History of Changes |
| Other Study ID Numbers: | NIS-NME-SER-2011/1 |
| Study First Received: | December 9, 2011 |
| Last Updated: | November 29, 2012 |
| Health Authority: | Romania: National Medicine and Medical Devices Agency Hungary: ETT-TUKEB (Hungarian Scientific Health Council) |
Keywords provided by AstraZeneca:
|
Schizophrenia antipsychotics real life treatment non-interventional |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features 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 16, 2013