Bipolar DisorderVIOLETNCT02006862
eVAluatIon of OLanzapine TreatmEnT
An observational study of Bipolar Disorder and Schizophrenia, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- How many people
- 468 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with schizophrenia or bipolar disorders
Who may be able to join
- 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-)
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- 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
Who cannot join
- 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 ,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Olanzapine in Standard Clinical Practice. 6-month Efficacy and Safety Monitoring
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) .
Read more
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 .
Read the detailed description
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
- Sertindole used in patients who can not tolerate at least one of the remaining APS
- Advantages monotherapy
- The dose of medication ( FA ) is preferable to the lower limits of normal dose as defined
- The appropriate duration of therapy should be continued for 12-24 months after the recession of the episode .
Treatment of acute phase .
- first-line treatment is oral second generation APS . The doses appropriate to move within the therapeutic range as defined
- For patients who received first-generation APS and had either reduced efficacy or intolerable side effects, the treatment of choice is to switch to oral second-generation APS
- If patients receiving first-generation APS with good response and no side effects , remain in these
- The length of acute treatment is six weeks less
- Where there is a risk of increased body weight ( BW) or onset of diabetes mellitus ( DM ) as the treatment with atypical APS requires close monitoring and control routine Investigations
- After the acute phase and high rates of relapse , treatment appropriate to continue for 12-24 months
- If it is determined appropriate treatment discontinuation should be done gradually and with close monitoring to identify relapse symptoms
- In cases of acute psychotic and / or stimulants patients is necessary rapidly quelled . In these cases, the oral preparations are to be preferred . If required injectable formulations , the drugs of choice is lorazepam , haloperidol , olanzapine , ziprasidone , aripiprazole intramuscular administration.
- In each case of using haloperidol appropriate be combined with anticholinergic . Is not necessary to monitor the vital signs of the patient.
Maintenance therapy , relapse prevention
- If the patient has benefits the acute phase of a particular FA continue the same
- For oral or injectable long-acting antipsychotic used in maintenance therapy
- For patients who received first-generation APS who had either reduced efficacy or intolerable side effects, the treatment of choice is to switch to oral second -generation APS
- If patients receiving first-generation APS with good response and no side effects , remain in these
- Where there is a risk of increased OR for diabetes or as to the treatment with atypical antipsychotics should be closely monitored and Investigations routine check or even switch to another atypical or typical APS
- If the patient is happy with a VAT does not modify
- We prefer monotherapy
- The duration of therapy appropriate to be extended by 5.2 years for patients with a relapse and more than five years (perhaps lifelong ) for more than one relapse
- If the patient has received at least two APS ( including one informal ) for at least 6-8 weeks each without adequate clinical response , consider the resistant form of the disease and the possibility of using clozapine . In some cases it is useful to add a second APS to treatment with clozapine
- Long-acting APS is an option for the treatment if the patient's wishes or when there are issues of adherence to treatment. The long acting formulations should be prescribed to a specified limit . resistant schizophrenia
- Examine possible factors of non-response in FA : dose , duration, compliance , substance abuse , physical illness , polypharmacy
- If the disease is refractory to treatment with standard APS , the clinician may initially tried using informal APS
- If the patient has received at least two APS ( including one informal ) for at least 6-8 weeks each without adequate clinical response , consider the resistant form of the disease and the possibility of using clozapine as soon as possible
- In some cases it is useful to add a second APS to treatment with clozapine .
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
- Necessary discontinuation of antidepressants.
- When selecting the first choice drug taken into account the personal and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions , symptoms of mania ( euphoric , dysphoric , psychotic ) and cost.
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 :
- Conventional antipsychotics ( haloperidol , chlorpromazine )
- Other atypical antipsychotics ( clozapine , paliperidone )
- Lithium or valproate + haloperidol
- carbamazepine
- Lithium + valproate , lithium + carbamazepine
- Electroconvulsive
Resistant cases:
- Add or change amisulpride , nimodipine
Not recommended :
- Monotherapy with gabapentin , pregabalin , topiramate , lamotrigine , tiagabine , verapamil
- Risperidone or olanzapine + carbamazepine
- Recommended treatment continued for at least 6-12 months after remission .
- Strong dose reduction after the recession as tolerated . B. Depressive Episode
Step 1 - Cure first choice :
- Lithium , lamotrigine , quetiapine
- Lithium or divalproex + SSRI or bupropion, olanzapine + SSRI, lithium + valproate
- When selecting the first choice drug taken into account the personal and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions, severity of depression, suicidality , and cost.
- Antidepressants , when granted , should always be combined with antimanic agent ( lithium, valproate , atypical antipsychotic )
- When coexisting psychotic symptoms should be added and atypical antipsychotic .
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 :
- Quetiapine + SSRI
- Valproate , lithium or valproate + lamotrigine
Step 4 - Treatment option 3 ( inadequate response after 4 weeks) :
- Carbamazepine , lithium + carbamazepine
- Olanzapine
- Lithium or valproate + venlafaxine or mirtazapine , lithium or valproate or atypical antipsychotic + tricyclic antidepressant , lithium + MAO inhibitor
- Lithium or valproate or carbamazepine + SSRI + lamotrigine
- Electroconvulsive therapy : particularly in patients with severe stroke, accompanying psychotic or catatonic symptoms , high risk of suicidality , refusing to take food , pregnancy may be the first choice
Not recommended :
- Monotherapy with gabapentin
- Monotherapy with aripiprazole
- Recommended maintenance antidepressant to 12 weeks and then gradually discontinued within four weeks unless diversion occurs in mania or hypomania earlier.
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 )
- When selecting the first choice drug taken into account the personal and family history of response to treatment , tolerance , contraindications , drug interactions , gender , comorbid conditions, compliance history , the prevalence of manic or depressive symptoms and costs.
- a) When prevailing manic / hypomanic episodes : lithium, valproate , aripiprazole , quetiapine , olanzapine monotherapy or combinations b ) When the prevailing depressive episodes quetiapine or lamotrigine antimanic + ( + antidepressant in a limited number of patients )
Treatment 2nd choice :
- carbamazepine
- Lithium + valproate , lithium + carbamazepine , lamotrigine , lithium +
- Lithium or divalproex + olanzapine , lithium + risperidone , olanzapine + fluoxetine
Treatment option 3 :
- Adjunctive therapy with gabapentin
- Adjunctive therapy with clozapine
- Adjunctive therapy with omega- 3 fatty acids
- Additional maintenance electroconvulsive therapy
We recommended :
- Monotherapy : gabapentin , topiramate , antidepressants
- It is recommended continued treatment for at least 2 years after an episode of illness and up to 5 years if there are risk factors for relapse ( substance use , psychotic symptoms , history of frequent relapses , ongoing stressful life events , poor psychosocial support)
- Recommended continued treatment indefinitely if it is effective in preventing recurrence .
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
- Preferred antidepressants (SSRIs, SNRIs) when coexisting depression .
- When selecting the first choice drug taken into account the individual and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions , the risk of suicidality and costs.
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 :
- quetiapine
- Benzodiazepines ( alprazolam , diazepam ) when there is no history dependence
- hydroxyzine
- buspirone
Resistant cases:
- Add another atypical antipsychotic ( olanzapine , risperidone )
- Addition of valproate
- Addition of a beta-blocker ( control somatic symptoms) Recommended continued treatment for at least 6-12 months after response. Panic Disorder
Step 1 - Cure first choice :
- SSRIs ( escitalopram , paroxetine , sertraline , citalopram , fluvoxamine , fluoxetine) or venlafaxine with or without benzodiazepines ( alprazolam , diazepam , lorazepam to 2-4 weeks )
- Monotherapy with benzodiazepines for 2-4 weeks when not coexist depressive symptoms • 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 :
- Switch to clomipramine
- Addition of benzodiazepines ( alprazolam , diazepam , lorazepam ) for longer periods of time when there is no history dependence
Resistant cases:
- Combination of drugs first or second choice ( eg clomipramine or SSRI + venlafaxine )
- Addition of atypical antipsychotic
- Addition of valproate or lithium
- Addition or change to mirtazapine
- Change in moclobemide Recommended continued treatment at the same dose for at least 12-24 months after response . Social Anxiety Disorder ( Social Phobia )
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 :
- Change in moclobemide
- Addition of a benzodiazepine ( clonazepam ) for longer periods of time when there is no history dependence
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
- usually needed higher doses than for addressing depression or other anxiety disorders .
- When selecting the first choice drug taken into account the individual and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions , the risk of suicidality and costs.
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 :
- Citalopram , escitalopram , fluvoxamine , moclobemide
- Olanzapine , quetiapine
- carbamazepine
Resistant cases:
- A combination of the first or second drug of choice
- Addition of olanzapine , risperidone , quetiapine Recommended continued treatment at the same dose for at least 6-12 months after response .
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- olanzapine, olanzapine treatment efficacy
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| olanzapine, schizophrenia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scales' ratings to assess efficacy
change in PANSS rating change in Y-MRS rating change in CES-D rating
Measured: baseline, 3 months, 6 months
Secondary outcomes (1)
Safety assessment
Number of Adverse Events - Serious Adverse Events
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006862
- Sponsor's protocol ID
- 2013-OLZ-EL-40
- Acronym
- VIOLET
- Status last verified
- Aug 2014
- First submitted
- 2 Dec 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine in Standard Clinical Practice. 6-month Efficacy and Safety Monitoring
- ClinicalTrials.gov ID
- NCT02006862
- Acronym / sponsor ID
- VIOLET / 2013-OLZ-EL-40
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- olanzapine, olanzapine treatment efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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
- Sertindole used in patients who can not tolerate at least one of the remaining APS
- Advantages monotherapy
- The dose of medication ( FA ) is preferable to the lower limits of normal dose as defined
- The appropriate duration of therapy should be continued for 12-24 months after the recession of the episode .
Treatment of acute phase .
- first-line treatment is oral second generation APS . The doses appropriate to move within the therapeutic range as defined
- For patients who received first-generation APS and had either reduced efficacy or intolerable side effects, the treatment of choice is to switch to oral second-generation APS
- If patients receiving first-generation APS with good response and no side effects , remain in these
- The length of acute treatment is six weeks less
- Where there is a risk of increased body weight ( BW) or onset of diabetes mellitus ( DM ) as the treatment with atypical APS requires close monitoring and control routine Investigations
- After the acute phase and high rates of relapse , treatment appropriate to continue for 12-24 months
- If it is determined appropriate treatment discontinuation should be done gradually and with close monitoring to identify relapse symptoms
- In cases of acute psychotic and / or stimulants patients is necessary rapidly quelled . In these cases, the oral preparations are to be preferred . If required injectable formulations , the drugs of choice is lorazepam , haloperidol , olanzapine , ziprasidone , aripiprazole intramuscular administration.
- In each case of using haloperidol appropriate be combined with anticholinergic . Is not necessary to monitor the vital signs of the patient.
Maintenance therapy , relapse prevention
- If the patient has benefits the acute phase of a particular FA continue the same
- For oral or injectable long-acting antipsychotic used in maintenance therapy
- For patients who received first-generation APS who had either reduced efficacy or intolerable side effects, the treatment of choice is to switch to oral second -generation APS
- If patients receiving first-generation APS with good response and no side effects , remain in these
- Where there is a risk of increased OR for diabetes or as to the treatment with atypical antipsychotics should be closely monitored and Investigations routine check or even switch to another atypical or typical APS
- If the patient is happy with a VAT does not modify
- We prefer monotherapy
- The duration of therapy appropriate to be extended by 5.2 years for patients with a relapse and more than five years (perhaps lifelong ) for more than one relapse
- If the patient has received at least two APS ( including one informal ) for at least 6-8 weeks each without adequate clinical response , consider the resistant form of the disease and the possibility of using clozapine . In some cases it is useful to add a second APS to treatment with clozapine
- Long-acting APS is an option for the treatment if the patient's wishes or when there are issues of adherence to treatment. The long acting formulations should be prescribed to a specified limit . resistant schizophrenia
- Examine possible factors of non-response in FA : dose , duration, compliance , substance abuse , physical illness , polypharmacy
- If the disease is refractory to treatment with standard APS , the clinician may initially tried using informal APS
- If the patient has received at least two APS ( including one informal ) for at least 6-8 weeks each without adequate clinical response , consider the resistant form of the disease and the possibility of using clozapine as soon as possible
- In some cases it is useful to add a second APS to treatment with clozapine .
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
- Necessary discontinuation of antidepressants.
- When selecting the first choice drug taken into account the personal and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions , symptoms of mania ( euphoric , dysphoric , psychotic ) and cost.
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 :
- Conventional antipsychotics ( haloperidol , chlorpromazine )
- Other atypical antipsychotics ( clozapine , paliperidone )
- Lithium or valproate + haloperidol
- carbamazepine
- Lithium + valproate , lithium + carbamazepine
- Electroconvulsive
Resistant cases:
- Add or change amisulpride , nimodipine
Not recommended :
- Monotherapy with gabapentin , pregabalin , topiramate , lamotrigine , tiagabine , verapamil
- Risperidone or olanzapine + carbamazepine
- Recommended treatment continued for at least 6-12 months after remission .
- Strong dose reduction after the recession as tolerated . B. Depressive Episode
Step 1 - Cure first choice :
- Lithium , lamotrigine , quetiapine
- Lithium or divalproex + SSRI or bupropion, olanzapine + SSRI, lithium + valproate
- When selecting the first choice drug taken into account the personal and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions, severity of depression, suicidality , and cost.
- Antidepressants , when granted , should always be combined with antimanic agent ( lithium, valproate , atypical antipsychotic )
- When coexisting psychotic symptoms should be added and atypical antipsychotic .
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 :
- Quetiapine + SSRI
- Valproate , lithium or valproate + lamotrigine
Step 4 - Treatment option 3 ( inadequate response after 4 weeks) :
- Carbamazepine , lithium + carbamazepine
- Olanzapine
- Lithium or valproate + venlafaxine or mirtazapine , lithium or valproate or atypical antipsychotic + tricyclic antidepressant , lithium + MAO inhibitor
- Lithium or valproate or carbamazepine + SSRI + lamotrigine
- Electroconvulsive therapy : particularly in patients with severe stroke, accompanying psychotic or catatonic symptoms , high risk of suicidality , refusing to take food , pregnancy may be the first choice
Not recommended :
- Monotherapy with gabapentin
- Monotherapy with aripiprazole
- Recommended maintenance antidepressant to 12 weeks and then gradually discontinued within four weeks unless diversion occurs in mania or hypomania earlier.
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 )
- When selecting the first choice drug taken into account the personal and family history of response to treatment , tolerance , contraindications , drug interactions , gender , comorbid conditions, compliance history , the prevalence of manic or depressive symptoms and costs.
- a) When prevailing manic / hypomanic episodes : lithium, valproate , aripiprazole , quetiapine , olanzapine monotherapy or combinations b ) When the prevailing depressive episodes quetiapine or lamotrigine antimanic + ( + antidepressant in a limited number of patients )
Treatment 2nd choice :
- carbamazepine
- Lithium + valproate , lithium + carbamazepine , lamotrigine , lithium +
- Lithium or divalproex + olanzapine , lithium + risperidone , olanzapine + fluoxetine
Treatment option 3 :
- Adjunctive therapy with gabapentin
- Adjunctive therapy with clozapine
- Adjunctive therapy with omega- 3 fatty acids
- Additional maintenance electroconvulsive therapy
We recommended :
- Monotherapy : gabapentin , topiramate , antidepressants
- It is recommended continued treatment for at least 2 years after an episode of illness and up to 5 years if there are risk factors for relapse ( substance use , psychotic symptoms , history of frequent relapses , ongoing stressful life events , poor psychosocial support)
- Recommended continued treatment indefinitely if it is effective in preventing recurrence .
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
- Preferred antidepressants (SSRIs, SNRIs) when coexisting depression .
- When selecting the first choice drug taken into account the individual and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions , the risk of suicidality and costs.
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 :
- quetiapine
- Benzodiazepines ( alprazolam , diazepam ) when there is no history dependence
- hydroxyzine
- buspirone
Resistant cases:
- Add another atypical antipsychotic ( olanzapine , risperidone )
- Addition of valproate
- Addition of a beta-blocker ( control somatic symptoms) Recommended continued treatment for at least 6-12 months after response. Panic Disorder
Step 1 - Cure first choice :
- SSRIs ( escitalopram , paroxetine , sertraline , citalopram , fluvoxamine , fluoxetine) or venlafaxine with or without benzodiazepines ( alprazolam , diazepam , lorazepam to 2-4 weeks )
- Monotherapy with benzodiazepines for 2-4 weeks when not coexist depressive symptoms • 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 :
- Switch to clomipramine
- Addition of benzodiazepines ( alprazolam , diazepam , lorazepam ) for longer periods of time when there is no history dependence
Resistant cases:
- Combination of drugs first or second choice ( eg clomipramine or SSRI + venlafaxine )
- Addition of atypical antipsychotic
- Addition of valproate or lithium
- Addition or change to mirtazapine
- Change in moclobemide Recommended continued treatment at the same dose for at least 12-24 months after response . Social Anxiety Disorder ( Social Phobia )
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 :
- Change in moclobemide
- Addition of a benzodiazepine ( clonazepam ) for longer periods of time when there is no history dependence
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
- usually needed higher doses than for addressing depression or other anxiety disorders .
- When selecting the first choice drug taken into account the individual and family history of response to treatment , tolerance , contraindications , drug interactions , comorbid conditions , the risk of suicidality and costs.
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 :
- Citalopram , escitalopram , fluvoxamine , moclobemide
- Olanzapine , quetiapine
- carbamazepine
Resistant cases:
- A combination of the first or second drug of choice
- Addition of olanzapine , risperidone , quetiapine Recommended continued treatment at the same dose for at least 6-12 months after response .
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| olanzapine, schizophrenia | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia or bipolar disorders
Key inclusion criteria (10 listed)
- Age 18 years and over
Key exclusion criteria (10 listed)
- Hypersensitivity to the active substance or to any of the ingredients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in scales' ratings to assess efficacy
Time frame: baseline, 3 months, 6 months
change in PANSS rating change in Y-MRS rating change in CES-D rating
1 secondary outcome
Safety assessment
Time frame: baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Schizophrenia, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scales' ratings to assess efficacy (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.