Non-interventional Study: Real-life Use of Atypical Antipsychotics in Acute Inpatient Management of Schizophrenia

Schizophrenia Clinical Trial

Official title:

RECONNECT-S GAMMA : 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: NCT01491412
• Other study ID #: NIS-NME-SER-2011/1
• Status: Completed
• Phase: N/A
• First received: December 9, 2011
• Last updated: November 29, 2012
• Start date: December 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicine and Medical Devices AgencyHungary: ETT-TUKEB (Hungarian Scientific Health Council)
• Study type: Observational

Clinical Trial Summary

This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.

In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.

The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.

Description:

RECONNECT-S GAMMA : A non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).

• 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

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: Prospective

Related Conditions & MeSH terms

• Acute Psychotic Episode
• Schizophrenia

Locations

Country	Name	City	State
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Kerepestarcsa
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Szekszard
Latvia	Research Site	Daugavpils
Latvia	Research Site	Jelgava
Latvia	Research Site	Liepaja
Latvia	Research Site	Riga
Latvia	Research Site	Strenci
Romania	Research Site	Bucharest
Romania	Research Site	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Hungary,  Latvia,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of used 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 2 weeks (variable per patient)	No
Primary	Description of the 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 2 weeks (variable per patient)	No
Primary	Description of 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 2 weeks (variable per patient)	No
Secondary	Percent of patients with atypical antipsychotic as monotherapy		hospitalisation period, an expected average of 2 weeks (variable per patient)	No
Secondary	Percent of patients with combinations of antipsychotics.		hospitalisation period, an expected average of 2 weeks (variable per patient)	No
Secondary	Description of main criteria used for selection of an antipsychotic during hospitalisation.		hospitalisation period, an expected average of 2 weeks (variable per patient)	No
Secondary	Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.		hospitalisation period, an expected average of 2 weeks (variable per patient)	No
Secondary	Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization		hospitalisation period, an expected average of 2 weeks (variable per patient)	No
Secondary	Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge		hospitalisation period, an expected average of 2 weeks (variable per patient)	No
Secondary	Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.		hospitalisation period, an expected average of 2 weeks (variable per patient)	No