A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia (RECONNECT-S)
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 12, 2011 | ||||||||
| Last Updated Date | November 2, 2012 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01394601 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia | ||||||||
| Official Title ICMJE | RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia | ||||||||
| Brief Summary | 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. |
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| Detailed Description | RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: None Retained Description: Clinical Practice |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Clinical Practice |
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| Condition ICMJE | Schizophrenia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 600 | ||||||||
| Completion Date | December 2011 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Russian Federation | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01394601 | ||||||||
| Other Study ID Numbers ICMJE | NIS-NRU-ATC-2011/1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | AstraZeneca | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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