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A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia (RECONNECT-S)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01394601
First received: July 12, 2011
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Number of antipsychotics used during the hospitalization due to an acutely agitated psychotic episode. Use of treatment concomitant to antipsychotics during the hospitalization [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Clinical Practice


Enrollment: 600
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of 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

Clinical Practice

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394601

Locations
Russian Federation
Research Site
Chita, Russian Federation
Research Site
Ekaterinburg, Russian Federation
Research Site
Ivanovo, Russian Federation
Research Site
Krasnodar, Russian Federation
Research Site
Moscow, Russian Federation
Clinical Site
Novosibirsk, Russian Federation
Clinical Site
S-Petersburg, Russian Federation
Research Site
Samara, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alexey Stepanov AstraZeneca
Principal Investigator: Nikolay Govorin Chita State Medical Akademy of Roszdraw
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01394601     History of Changes
Other Study ID Numbers: NIS-NRU-ATC-2011/1
Study First Received: July 12, 2011
Last Updated: November 2, 2012
Health Authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials

Keywords provided by AstraZeneca:
Antipsychotics
schizophrenia
acute inpatient

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 May 22, 2013