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

Schizophrenia Clinical Trial

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Official title:

A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544608
• Other study ID #: NIS-NME-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: February 20, 2012
• Last updated: June 19, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and PopulationSaudi Arabia: Ministry of HealthUnited Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of HealthKuwait : Minstry of HealthQatar: Sheikh Hamad Medical Center Authority
• Study type: Observational

Clinical Trial 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.

Description:

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 1076
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Egypt	Research Site	Cairo
Saudi Arabia	Research Site	Dammam
Saudi Arabia	Research Site	Jeddah
Saudi Arabia	Research Site	Riyadh
United Arab Emirates	Research Site	Abu Dhabi
United Arab Emirates	Research Site	Dubai
United Arab Emirates	Research Site	Ras Al Khaimah

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Egypt,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of atypical antipsychotic(s) during hospitalisation.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Primary	Daily dosage of atypical antipsychotic(s) during hospitalisation.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Primary	Mode of administration of atypical antipsychotic(s) during hospitalisation.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Secondary	Percent of patients with atypical antipsychotic as monotherapy.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Secondary	Percent of patients with combinations of antipsychotics.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Secondary	Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Secondary	Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Secondary	Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No
Secondary	Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.	The data will be collected at one visit at the moment of discharge from the hospital.	Hospitalisation period, an expected average of 3 weeks (variable per patient).	No