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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
• The oral antipsychotics ( APS ) second generation ( atypical ) considered the treatment of choice : olanzapine , risperidone , quetiapine , aripiprazole , ziprasidone , amisulpride , paliperidone
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:
- Add or change amisulpride , nimodipine
Not recommended :
Monotherapy with gabapentin , pregabalin , topiramate , lamotrigine , tiagabine , verapamil
Risperidone or olanzapine + carbamazepine
Step 1 - Cure first choice :
Lithium , lamotrigine , quetiapine
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 gabapentin
Monotherapy with aripiprazole
CAUTION - MAINTENANCE
Treatment first choice :
Lithium (if probable good compliance in the future) , valproate ( avoided in women of childbearing age ) , lamotrigine
Aripiprazole, quetiapine , olanzapine , risperidone or risperidone depot
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 :
- Adjunctive therapy with gabapentin
We recommended :
- Monotherapy : gabapentin , topiramate , antidepressants
Anxiety & Related Disorders Generalised Anxiety Disorder
Step 1 - Cure first choice :
- The SSRIs escitalopram , paroxetine , sertraline or SNRIs venlafaxine, duloxetine with or without benzodiazepines ( alprazolam , diazepam to 2-4 weeks )- pregabalin
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 :
- SSRIs ( escitalopram , paroxetine , sertraline , citalopram , fluvoxamine , fluoxetine) or venlafaxine with or without benzodiazepines ( bromazepam , clonazepam to 2-4 weeks)
* 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:
The first choice drug combination ( eg SSRI + venlafaxine )
Addition of atypical antipsychotic ( olanzapine )
Addition of pregabalin
Addition or change to mirtazapine
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 haloperidol or atypical antipsychotic ( aripiprazole , quetiapine , olanzapine , risperidone )
Combination of SSRI + clomipramine
Addition or change to venlafaxine, mirtazapine
Addition of lithium
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
• When selecting the first choice drug taken into account the individual and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions and costs.
nd choice :
amitriptyline
mirtazapine
lamotrigine
risperidone
Option 3 :
Resistant cases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine, schizophrenia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Number of Adverse Events - Serious Adverse Events | baseline, 3 months, 6 months |
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Inclusion Criteria:
Age 18 years and over
Exclusion Criteria:
Hypersensitivity to the active substance or to any of the ingredients.
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Patients with schizophrenia or bipolar disorders
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agia Olga Konstantopouleion Hospital | Athens | Greece |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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