eVAluatIon of OLanzapine TreatmEnT

NCT02006862 | Completed

• 1 other identifier: 2013-OLZ-EL-40
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Bipolar Disorder; Schizophrenia

Keywords

olanzapine; olanzapine treatment efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety assessment

  baseline, 3 months, 6 months

Study Arms (1)

olanzapine, schizophrenia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with schizophrenia or bipolar disorders

You may qualify if:

• Age 18 years and over
• Diagnosis of schizophrenia (DSM-IV-DR)
• Maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response .
• Treatment of moderate to severe manic episode .
• Patients whose manic episode has responded to olanzapine treatment ,
• for the prevention of recurrence in patients with bipolar disorder (DSM-IV-)
• The patient has a reliable caregiver
• Signed consent form to participate in the study after informed by reliable caregiver of the patient or other witness
• The patient is treated with olanzapine before joining the present study
• The patient had conformability to study

You may not qualify if:

• Hypersensitivity to the active substance or to any of the ingredients.
• Patients with known risk for narrow-angle glaucoma .
• Dementia-related psychosis and / or behavioral disturbances
• Disease Parkinson
• Neuroleptic Malignant Syndrome (NMS)
• Patients with low leukocyte and / or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia ,
• Clinically significant laboratory and ECG abnormalities .
• Participation in another clinical study than this
• Refusal to sign the consent form to participate in the study after informed by reliable caregiver of the patient or other witness
• The patient is treated with olanzapine before joining the clinical trial

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Agia Olga Konstantopouleion Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2014-08

Locations

GR (1)