Clinical trial NCT01491412: Non-interventional Study: Real-life Use of Atypical Antipsychotics in Acute Inpatient Management of Schizophrenia
Official title: 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
Overall status: COMPLETED
Conditions: Acute Psychotic Episode
Schizophrenia
Keywords: Schizophrenia
antipsychotics
real life treatment
non-interventional
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode

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.

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 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)

Primary outcomes:
measure: Description of used atypical antipsychotic(s) during hospitalisation
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of the daily dosage of atypical antipsychotic(s) during hospitalisation
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of mode of administration of atypical antipsychotic(s) during hospitalisation
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Secondary outcomes:
measure: Percent of patients with atypical antipsychotic as monotherapy
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Percent of patients with combinations of antipsychotics.
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of main criteria used for selection of an antipsychotic during hospitalisation.
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
measure: Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.
timeFrame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kerepestarcsa
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szekszard
country: Hungary
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Jelgava
country: Latvia
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Strenci
country: Latvia
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
Study officials:
affiliation: Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania
name: Radu TEODORESCU, Prof.
role: PRINCIPAL_INVESTIGATOR
References: