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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01544608
First received: February 20, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Use of atypical antipsychotic(s) during hospitalisation. [ Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • Daily dosage of atypical antipsychotic(s) during hospitalisation. [ Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • Mode of administration of atypical antipsychotic(s) during hospitalisation. [ Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.


Secondary Outcome Measures:
  • Percent of patients with atypical antipsychotic as monotherapy. [ Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • Percent of patients with combinations of antipsychotics. [ Time Frame: Hospitalisation period, an expected average of 3 weeks (variable per patient). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • 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). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • 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). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • 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). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.

  • 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). ] [ Designated as safety issue: No ]
    The data will be collected at one visit at the moment of discharge from the hospital.


Enrollment: 1076
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

RECONNECT-S BETA

  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

Psychiatric Institutes

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544608

Locations
Egypt
Research Site
Cairo, Egypt
Saudi Arabia
Research Site
Dammam, Saudi Arabia
Research Site
Jeddah, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
United Arab Emirates
Research Site
Abu Dhabi, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Research Site
Ras Al Khaimah, United Arab Emirates
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01544608     History of Changes
Other Study ID Numbers: NIS-NME-XXX-2011/1
Study First Received: February 20, 2012
Last Updated: June 19, 2013
Health Authority: Egypt: Ministry of Health and Population
Saudi Arabia: Ministry of Health
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Kuwait : Minstry of Health
Qatar: Sheikh Hamad Medical Center Authority

Keywords provided by AstraZeneca:
Acute psychotic episode of Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014