Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01544608
• Lead Sponsor: AstraZeneca

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.

Detailed Description

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Study Timeline

• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Study Start: 2012-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1076

Inclusion Criteria

• Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria.
• Subject is hospitalised due to an acute psychotic episode.
• Ability of the subject to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion Criteria

• Current participation in any clinical trial.
• Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of atypical antipsychotic(s) during hospitalisation.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Daily dosage of atypical antipsychotic(s) during hospitalisation.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Mode of administration of atypical antipsychotic(s) during hospitalisation.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.

Secondary Outcome Measures

Name	Time	Method
Percent of patients with atypical antipsychotic as monotherapy.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Percent of patients with combinations of antipsychotics.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.
Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	The data will be collected at one visit at the moment of discharge from the hospital.

Trial Locations

Locations (1)

Research Site; 🇦🇪 Ras Al Khaimah, United Arab Emirates