Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia (RECONNECT-S)
This study is currently recruiting participants.
Verified December 2012 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01544608
First received: February 20, 2012
Last updated: December 11, 2012
Last verified: December 2012
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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.
| Estimated Enrollment: | 1050 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544608
Contacts
| Contact: AstraZeneca Gulf MC Clinical Study Information | +971508504952 | tamer.fadel@astrazeneca.com |
| Contact: Mohamed Elsayed | +971567552205 | Mohamed.elsayed@astrazeneca.com |
Locations
| Egypt | |
| Research Site | Recruiting |
| Cairo, Egypt | |
| Saudi Arabia | |
| Research Site | Recruiting |
| Dammam, Saudi Arabia | |
| Research Site | Recruiting |
| Jeddah, Saudi Arabia | |
| Research Site | Recruiting |
| Riyadh, Saudi Arabia | |
| United Arab Emirates | |
| Research Site | Recruiting |
| Abu Dhabi, United Arab Emirates | |
| Research Site | Recruiting |
| Dubai, United Arab Emirates | |
| Research Site | Recruiting |
| 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: | December 11, 2012 |
| 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 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 19, 2013