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

NCT01491412 | Completed

• 1 other identifier: NIS-NME-SER-2011/1
• Study Type: observational
• Target: 503
• Locations: 3 countries
• Sites: 14

Brief 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.

Conditions

Acute Psychotic Episode; Schizophrenia

Keywords

Schizophrenia; antipsychotics; real life treatment; non-interventional

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Secondary Outcomes (7)

• Percent of patients with atypical antipsychotic as monotherapy

  hospitalisation period, an expected average of 2 weeks (variable per patient)

• Percent of patients with combinations of antipsychotics.

  hospitalisation period, an expected average of 2 weeks (variable per patient)

• Description of main criteria used for selection of an antipsychotic during hospitalisation.

  hospitalisation period, an expected average of 2 weeks (variable per patient)

• 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)

• Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization

  hospitalisation period, an expected average of 2 weeks (variable per patient)

Study Arms (1)

Acute psychotic episode in schizophrenia

Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Győr, Hungary

Location

Research Site

Kistarcsa, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Szekszárd, Hungary

Location

Research Site

Székesfehérvár, Hungary

Location

Research Site

Daugavpils, Latvia

Location

Research Site

Jelgava, Latvia

Location

Research Site

Liepāja, Latvia

Location

Research Site

Riga, Latvia

Location

Research Site

Strenči, Latvia

Location

Research Site

Bucharest, Romania

Location

Research Site

Iași, Romania

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Radu TEODORESCU, Prof.

  Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 14, 2011
• Study Start: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

RO (2); LA (5); HU (7)