Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia (RECONNECT-S)

June 19, 2013 updated by: AstraZeneca

A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.

The primary objective of this Non- Interventional Study (NIS) is to describe the use of atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication.

Study Overview

Status

Completed

Conditions

Detailed Description

RECONNECT-S BETA

Study Type

Observational

Enrollment (Actual)

1076

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Research Site
  • Saudi Arabia
      • Dammam, Saudi Arabia
        • Research Site
      • Jeddah, Saudi Arabia
        • Research Site
      • Riyadh, Saudi Arabia
        • Research Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Research Site
      • Dubai, United Arab Emirates
        • Research Site
      • Ras Al Khaimah, United Arab Emirates
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Psychiatric Institutes

Description

Inclusion Criteria:

  • 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.
  • Ability of the subject to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion Criteria:

  • Current participation in any clinical trial.
  • Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Subjects who are hospitalized due to acute psychotic episode.
All subjects who are hospitalized due to acute psychotic episode. The subjects should be managed according to normal clinical practice until discharge time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of atypical antipsychotic(s) during hospitalisation.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Daily dosage of atypical antipsychotic(s) during hospitalisation.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Mode of administration of atypical antipsychotic(s) during hospitalisation.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients with atypical antipsychotic as monotherapy.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Percent of patients with combinations of antipsychotics.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).
Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.
Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Hospitalisation period, an expected average of 3 weeks (variable per patient).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Talaat Matar, CONSULTANT PSYCHIATRIST, Obaid Alla Hospital,Ras Al Khaima,UAE
  • Study Chair: Tarek Darwish, CONSULTANT PSYCHIATRIST, Sheikh Khalifa Medical City(SKMC), Abudhabi,UAE
  • Study Chair: Sohail Khan, CONSULTANT PSYCHIATRIST, Jeddah Psychiatric hospital,Jeddah, Saudi Arabia
  • Study Chair: Tarek Okasha, PROFESSOR, Ain Shams University, Cairo, Egypt
  • Study Chair: Mohamed Nasr, PROFESSOR, Cairo university, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NME-XXX-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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