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NCT Number: NCT01491412

Non-interventional Study: Real-life Use of Atypical Antipsychotics in 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.

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Key information

Conditions

Acute Psychotic Episode Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Budapest, Hungary

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Percent of patients with atypical antipsychotic as monotherapy

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

  2. Percent of patients with combinations of antipsychotics.

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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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