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

November 29, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • 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, Hungary
        • Research Site
  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Jelgava, Latvia
        • Research Site
      • Liepaja, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
      • Strenci, Latvia
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
      • Iasi, Romania
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute psychotic episode in schizophrenia
Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of used atypical antipsychotic(s) during hospitalisation
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
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
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
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
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
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 Outcome Measures

Outcome Measure
Time Frame
Percent of patients with atypical antipsychotic as monotherapy
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Percent of patients with combinations of antipsychotics.
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of main criteria used for selection of an antipsychotic during hospitalisation.
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
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.
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.
Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
hospitalisation period, an expected average of 2 weeks (variable per patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Radu TEODORESCU, Prof., Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 9, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NME-SER-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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