Clinical trial NCT01544608: Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia
Official title: A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Acute psychotic episode of Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 1076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psychiatric Institutes

Brief summary: 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.

Detailed description: RECONNECT-S BETA

Eligibility 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).

Primary outcomes:
measure: Use of atypical antipsychotic(s) during hospitalisation.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Daily dosage of atypical antipsychotic(s) during hospitalisation.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Mode of administration of atypical antipsychotic(s) during hospitalisation.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Secondary outcomes:
measure: Percent of patients with atypical antipsychotic as monotherapy.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Percent of patients with combinations of antipsychotics.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
measure: Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.
timeFrame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Research Site
city: Dammam
country: Saudi Arabia
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
city: Ras Al Khaimah
country: United Arab Emirates
facility: Research Site
Study officials:
affiliation: Obaid Alla Hospital,Ras Al Khaima,UAE
name: Talaat Matar, CONSULTANT PSYCHIATRIST
role: STUDY_CHAIR
affiliation: Sheikh Khalifa Medical City(SKMC), Abudhabi,UAE
name: Tarek Darwish, CONSULTANT PSYCHIATRIST
role: STUDY_CHAIR
affiliation: Jeddah Psychiatric hospital,Jeddah, Saudi Arabia
name: Sohail Khan, CONSULTANT PSYCHIATRIST
role: STUDY_CHAIR
affiliation: Ain Shams University, Cairo, Egypt
name: Tarek Okasha, PROFESSOR
role: STUDY_CHAIR
affiliation: Cairo University, Egypt
name: Mohamed Nasr, PROFESSOR
role: STUDY_CHAIR
References: