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

Schizophrenia Clinical Trial

— RECONNECT-S  

Official title:

RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394601
• Other study ID #: NIS-NRU-ATC-2011/1
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: November 2, 2012
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

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