A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01394601
• Lead Sponsor: AstraZeneca

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.

Detailed Description

RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia

Study Timeline

• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Study Start: 2011-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics.	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge.	up to 6 months
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
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

Trial Locations

Locations (2)

Research Site; 🇷🇺 Samara, Russian Federation

Clinical Site; 🇷🇺 S-Petersburg, Russian Federation