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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01491412
First received: December 9, 2011
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Acute Psychotic Episode
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of used atypical antipsychotic(s) during hospitalisation [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • Description of the daily dosage of atypical antipsychotic(s) during hospitalisation [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • Description of mode of administration of atypical antipsychotic(s) during hospitalisation [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.


Secondary Outcome Measures:
  • Percent of patients with atypical antipsychotic as monotherapy [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
  • Percent of patients with combinations of antipsychotics. [ Time Frame: hospitalisation period, an expected average of 2 weeks (variable per patient) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 503
Study Start Date: December 2011
Study Completion Date: May 2012
Groups/Cohorts
Acute psychotic episode in schizophrenia
Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491412

Locations
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, Hungary
Latvia
Research Site
Daugavpils, Latvia
Research Site
Jelgava, Latvia
Research Site
Liepaja, Latvia
Research Site
Riga, Latvia
Research Site
Strenci, Latvia
Romania
Research Site
Bucharest, Romania
Research Site
Iasi, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Radu TEODORESCU, Prof. Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01491412     History of Changes
Other Study ID Numbers: NIS-NME-SER-2011/1
Study First Received: December 9, 2011
Last Updated: November 29, 2012
Health Authority: Romania: National Medicine and Medical Devices Agency
Hungary: ETT-TUKEB (Hungarian Scientific Health Council)

Keywords provided by AstraZeneca:
Schizophrenia
antipsychotics
real life treatment
non-interventional

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014