A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia

NCT01394601 | Completed

• 1 other identifier: NIS-NRU-ATC-2011/1
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 8

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.

Conditions

Schizophrenia

Keywords

Antipsychotics; schizophrenia; acute inpatient

Outcome Measures

Primary Outcomes (1)

• Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics.

  up to 6 months

Secondary Outcomes (3)

• 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

  up to 6 months

• Number of antipsychotics used during the hospitalization due to an acutely agitated psychotic episode. Use of treatment concomitant to antipsychotics during the hospitalization

  up to 6 months

• Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge.

  up to 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical Practice

You may qualify if:

• male or female patients,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Chita, Russia

Location

Research Site

Ivanovo, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Moscow, Russia

Location

Clinical Site

Novosibirsk, Russia

Location

Clinical Site

S-Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Yekaterinburg, Russia

Location

Biospecimen

Retention: NONE RETAINED

Clinical Practice

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Alexey Stepanov

  AstraZeneca

  STUDY DIRECTOR

• Nikolay Govorin

  Chita State Medical Akademy of Roszdraw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 14, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 5, 2012

Record last verified: 2012-11

Locations

RU (8)