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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01394601
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : November 5, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease

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

Study Design

Study Type : Observational
Actual Enrollment : 600 participants
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
Study Start Date : August 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics. [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge. [ Time Frame: up to 6 months ]

Biospecimen Retention:   None Retained
Clinical Practice

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical Practice

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394601

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
Study Director: Alexey Stepanov AstraZeneca
Principal Investigator: Nikolay Govorin Chita State Medical Akademy of Roszdraw
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01394601     History of Changes
Other Study ID Numbers: NIS-NRU-ATC-2011/1
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: November 2012

Keywords provided by AstraZeneca:
acute inpatient

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs