|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01394601 |
|
Date of registration:
|
12/07/2011 |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia
RECONNECT-S |
|
Scientific title:
|
RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia |
|
Date of first enrolment:
|
August 2011 |
|
Target sample size:
|
600 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01394601 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Retrospective
|
|
|
Countries of recruitment
|
|
Russian Federation
| | | | | | | |
|
Contacts
|
|
Name:
|
Alexey Stepanov |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca |
|
|
Name:
|
Nikolay Govorin |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Chita State Medical Akademy of Roszdraw |
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Schizophrenia
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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]
|
|
Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge.
[Time Frame: up to 6 months]
|
|
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]
|
|
Secondary ID(s)
|
|
NIS-NRU-ATC-2011/1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|