Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia (RECONNECT-S)
This study is currently recruiting participants.
Verified December 2012 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01544608
First received: February 20, 2012
Last updated: December 11, 2012
Last verified: December 2012
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| First Received Date ICMJE | February 20, 2012 | ||||||||||||||||||||
| Last Updated Date | December 11, 2012 | ||||||||||||||||||||
| Start Date ICMJE | July 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01544608 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 | Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia | ||||||||||||||||||||
| Official Title ICMJE | A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia. | ||||||||||||||||||||
| Brief Summary | The primary objective of this Non- Interventional Study (NIS) is to describe the use of atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication. |
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| Detailed Description | RECONNECT-S BETA |
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| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||||||
| Study Population | Psychiatric Institutes |
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| Condition ICMJE | Schizophrenia | ||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||
| Study Group/Cohort (s) | Subjects who are hospitalized due to acute psychotic episode.
All subjects who are hospitalized due to acute psychotic episode. The subjects should be managed according to normal clinical practice until discharge time. |
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| 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 | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 1050 | ||||||||||||||||||||
| Estimated Completion Date | December 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | December 2012 (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 |
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| Location Countries ICMJE | Egypt, Saudi Arabia, United Arab Emirates | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01544608 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | NIS-NME-XXX-2011/1 | ||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||
| Responsible Party | AstraZeneca | ||||||||||||||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||||||||||||||
| Verification Date | December 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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