Clinical trial NCT01394601: A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia
Official title: RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Antipsychotics
schizophrenia
acute inpatient
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical Practice

Brief summary: RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. The patients should be managed according to normal clinical practice until discharge time. Data will be collected by review of medical records of the hospitalisation prior the study visit. During the study the patients will conduct one visit on the day of their discharge after hospitalisation due to an acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and medical history will be recorded. Data on antipsychotic and concomitant medication will be collected by review of medical records.

Detailed description: RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia

Eligibility criteria: Inclusion Criteria:

* male or female patients,
* 18 years or older,
* meeting the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders,
* meeting 4th edition (DSM-IV) criteria hospitalization due to an acutely agitated psychotic episode.

Exclusion Criteria:

* patient in acutely agitated state upon discharge from the hospital,
* current participation in any clinical trial,
* previous enrolment in the present NIS.

Primary outcomes:
measure: Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics.
timeFrame: up to 6 months
Secondary outcomes:
measure: Treatment with of only one antipsychotic during the hospitalization.Use of psychometric scales to evaluate the disease symptoms. Relationship between the patient characteristics and the use of antipsychotic during hospitalisation and after discharge
timeFrame: up to 6 months
measure: Number of antipsychotics used during the hospitalization due to an acutely agitated psychotic episode. Use of treatment concomitant to antipsychotics during the hospitalization
timeFrame: up to 6 months
measure: Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Chita
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Clinical Site
city: S-Petersburg
country: Russian Federation
facility: Clinical Site
city: Samara
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov
role: STUDY_DIRECTOR
affiliation: Chita State Medical Akademy of Roszdraw
name: Nikolay Govorin
role: PRINCIPAL_INVESTIGATOR
References: