Schizophrenia Clinical Trial
— RECONNECT-SOfficial title:
RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia
RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. The patients should be managed according to normal clinical practice until discharge time. Data will be collected by review of medical records of the hospitalisation prior the study visit. During the study the patients will conduct one visit on the day of their discharge after hospitalisation due to an acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and medical history will be recorded. Data on antipsychotic and concomitant medication will be collected by review of medical records.
Status | Completed |
Enrollment | 600 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - male or female patients, - 18 years or older, - meeting the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, - meeting 4th edition (DSM-IV) criteria hospitalization due to an acutely agitated psychotic episode. Exclusion Criteria: - patient in acutely agitated state upon discharge from the hospital, - current participation in any clinical trial, - previous enrolment in the present NIS. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Site | Chita | |
Russian Federation | Research Site | Ekaterinburg | |
Russian Federation | Research Site | Ivanovo | |
Russian Federation | Research Site | Krasnodar | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Clinical Site | Novosibirsk | |
Russian Federation | Clinical Site | S-Petersburg | |
Russian Federation | Research Site | Samara |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics. | up to 6 months | No | |
Secondary | Treatment with of only one antipsychotic during the hospitalization.Use of psychometric scales to evaluate the disease symptoms. Relationship between the patient characteristics and the use of antipsychotic during hospitalisation and after discharge | up to 6 months | No | |
Secondary | Number of antipsychotics used during the hospitalization due to an acutely agitated psychotic episode. Use of treatment concomitant to antipsychotics during the hospitalization | up to 6 months | No | |
Secondary | Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge. | up to 6 months | No |
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