An observational study in Bipolar Disorder and Schizophrenia, sponsored by Elpen Pharmaceutical Co. Inc.. Completed at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Elpen Pharmaceutical Co. Inc. · Observational
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 .
Schizophrenia
Treatment may be divided as follows :
Treating first episode- Treatment of acute- Maintenance therapy , relapse prevention - Treatment -resistant schizophrenia Treating first episode
Treatment of acute phase .
Maintenance therapy , relapse prevention
resistant schizophrenia
Bipolar I Disorder A. manic / hypomanic or mixed EPISODE Step 1 - the first choice therapy : lithium, valproate , atypical antipsychotics ( aripiprazole, ziprasidone , quetiapine , olanzapine, risperidone ) , lithium or valproate + atypical antipsychotics ( aripiprazole, ziprasidone , quetiapine , olanzapine, risperidone ) with or without a benzodiazepine ( lorazepam ) at severe mania
Step 2 (for inadequate response after 2 weeks) :
Optimizing a dose control in plasma levels , compliance check b Change to another drug first choice c Add another drug first choice
Step 3 (for inadequate response after an additional 2-4 weeks ) :
a change to another drug first choice b Start the second treatment option :
Resistant cases:
Not recommended :
Risperidone or olanzapine + carbamazepine
Step 1 - Cure first choice :
Lithium or divalproex + SSRI or bupropion, olanzapine + SSRI, lithium + valproate
Step 2 ( inadequate response after 4 weeks) :
Optimizing a dose control in plasma levels , compliance check b Add or change to another treatment first choice
Step 3 ( inadequate response after 4 weeks) :
a change to another drug first choice b Start the second treatment option :
Step 4 - Treatment option 3 ( inadequate response after 4 weeks) :
Not recommended :
Monotherapy with aripiprazole
CAUTION - MAINTENANCE
Treatment first choice :
Lithium or valproate + quetiapine adjunctive treatment with risperidone or risperidone depot, additional treatment with ziprasidone • Start after a severe manic episode or after two episodes ( manic , mixed or depressive )
Treatment 2nd choice :
Treatment option 3 :
We recommended :
Anxiety \& Related Disorders Generalised Anxiety Disorder
Step 1 - Cure first choice :
Step 2 (for insufficient response after 8-12 weeks ) :
a dose increase b change to another drug first choice c addition or change to the second drug of choice :
Resistant cases:
Step 1 - Cure first choice :
Step 2 (for insufficient response after 8-12 weeks ) :
a dose increase b change to another drug first choice c Treatments second choice :
Resistant cases:
Step 1 - Cure first choice :
* When selecting the first choice drug taken into account the individual and family history of response to treatment , tolerance , contraindications , the drug interactions , comorbid conditions , risk suicidality and costs.
Step 2 (for insufficient response after 8-12 weeks ) :
a dose increase b change to another drug first choice c Treatments second choice :
Resistant cases:
Addition of buspirone Recommended continued treatment at the same dose for at least 6-12 months after response . obsessive Compulsive Disorder Step 1 - Cure first choice : - SSRIs ( escitalopram , paroxetine , sertraline , citalopram , fluvoxamine , fluoxetine) with titration to the maximum tolerated dose
Step 2 (for inadequate response after 8 to 12 weeks, of which at least 4-6 weeks at the maximum tolerated dose) : a change to another drug first choice b switch to clomipramine (2nd choice )
Resistant cases:
Addition of buspirone Recommended continued treatment at the same dose for at least 12-24 months after response . Post Traumatic Stress Disorder
st choice : paroxetine , sertraline , fluoxetine or venlafaxine
Option 3 :
Resistant cases:
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 468 is above the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 43 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with schizophrenia or bipolar disorders
Age 18 years and over
Exclusion Criteria:
Hypersensitivity to the active substance or to any of the ingredients.
Change in scales' ratings to assess efficacy
change in PANSS rating change in Y-MRS rating change in CES-D rating
Time frame: baseline, 3 months, 6 months
Safety assessment
Number of Adverse Events - Serious Adverse Events
Time frame: baseline, 3 months, 6 months
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Elpen Pharmaceutical Co. Inc.