eVAluatIon of OLanzapine TreatmEnT
VIOLET
Olanzapine in Standard Clinical Practice. 6-month Efficacy and Safety Monitoring
VIOLET
Olanzapine in Standard Clinical Practice. 6-month Efficacy and Safety Monitoring
Sponsor study identifier
observational
468
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)This clinical observational study aims to investigate the efficacy of olanzapine (Villamos ®) in accordance with the instructions attached thereto in standard clinical practice, followed by the physician to the patient. This is a multicenter, non- interventional observational study , 6-month period without preparing the patient to take the usual his medication . A total of 3 scheduled visits : Visit 1 to Day 0 ( integration , base ) , Visit 2 at month 3 and Visit 3 at month 6 ( = end of treatment) . The purpose of the study is to demonstrate the efficacy and safety of olanzapine in patients who are indicated . Will be monitored and recorded all the different concomitant therapy . The treatment of each patient is an individual designated by the physician , according to standard clinical practice and without any intervention research purpose . During the six months of observation patients visit the clinic at the beginning (day 0 ), intermediate ( 3 months ) and end (month 6). The purpose of these visits is regularly monitored by their doctor for senile dementia and their behavior .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2013
Actual (reported)December 10, 2013
Actual (reported)January 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)December 2014
Actual (reported)Change in scales' ratings to assess efficacy
change in PANSS rating change in Y-MRS rating change in CES-D rating
baseline, 3 months, 6 months
Safety assessment
baseline, 3 months, 6 months
Patients with schizophrenia or bipolar disorders
Agia Olga Konstantopouleion Hospital
Athens, Greece
468 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2013
First Posted
December 10, 2013
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder
Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
March 17, 2015
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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