Bipolar DisorderPhase 4NCT00191997
Optimal Length of Treatment Continuation With Olanzapine After Remission of Manic or Mixed Episode
A Phase 4 study testing Olanzapine in people with Bipolar Disorder, run by Eli Lilly and Company at 11 sites in Spain.
Trial summary
This is a randomized, parallel, open-label study of patients who have responded to treatment in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the time of enrollment into the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Olanzapine
- How many people
- 180 participants
- Where
- 11 sitesSpain
- Study dates
- Oct 2004to Mar 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients, male or female, at least 18 years old
- Patient or legal representative must understand the study and sign an informed consent document before any study procedure
- Must have a diagnosis of Bipolar Disorder type I and have a recent manic or mixed episode, with or without hospitalization, according to DSM-IV-TR criteria.
- Patients must be in syndromic and symptomatic remission, following DSM-IV-IR criteria, for the manic or mixed episode, at the time of study entry, with a total score for YMRS less than or equal to 12 and total store for HAMD less than or equal to 8 at visit 1 and 2.
- Remission must have been achieved taking olanzapine in mono or co-therapy, and it must have been maintained until study entry.
- Patients must have had, at least, 2 manic or mixed episodes within 3 years of the study entry, taking into account the current one.
Who cannot join
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry, or with a study drug in other clinical trial
- Patients without symptoms or manic or mixed episode within one month of study entry.
- Confirmed diagnoses of Schizophrenia or other psychotic disorders (schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, substance-induced or medical condition psychotic disorder, psychotic disorder NOS),following DSM-IV-TR criteria.
- Patients that have achieved remission with ECT (electro convulsive therapy) in addition to psychopharmacological treatment
- Drug dependence or abuse, if it is a primary diagnose and the mood disorder is due to his administration
- Patients that at the time of study entry or at any other time of study, need treatment with antiepileptics or other substances with potential effect as mood stabilizers (i,e new antiepileptics different to Lithium, Valproic Acid and/or Carbamazepine
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Barcelona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
León
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Lleida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Madrid
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Murcia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Ourense
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Salamanca
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Seville
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Tarrasa-Barcelona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Vitoria-Gasteiz
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Zamora
About this study
Official title: Optimal Treatment Duration With Olanzapine Following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies.
This is a randomized, parallel, open-label study of patients who have responded to treatment in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the time of enrollment into the study.
- Conditions
- Bipolar Disorder
- Being tested
- Olanzapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective of this study is to compare the efficacy in the prevention of relapse to manic, depressive, or
mixed episodes in two groups of bipolar I patients
who responded to open-label treatment with olanzapine in mono or co-therapy and who are in symptomatic and syndromic remission at the time of entering the study.
The first group will receive olanzapine for a period of
3 months following inclusion into the study; the second group will receive olanzapine for 12 months.
Relapses will be evaluated in terms of the total YMRS
(Young Mania Rating Scale) and HAMD-21 (the 21-item Hamilton Depression Rating Scale) scores.
Secondary outcomes (28)
The secondary objectives posed by this study are the following:
To compare the efficacy of maintaining olanzapine for 3 months versus maintaining it for 12 months in
the improvement of symptomatology in patients who had achieved remission. To this end, the reductions
on the total YMRS score, YMRS specific non-psychotic
item scores, HAMD 21 total score, the scores on the
HAMD 21 specific mood-related items, the total and
positive scores on the BPRS (Brief Psychiatric Rating Scale), and the CGI BP S(Clinical Global Impression of Severity) with respect to baseline will be evaluated.
DSM IV TR criteria will be used for manic and
depressive episodes in order to assess syndromic improvement.
To compare the efficacy of long-term treatments by means of longitudinal assessment using the
general subscale of the CGI BP M (Clinical Global Impression - Modified) and proceeding to
intra- and intergroup analyses.
To evaluate the safety of maintenance treatment
with olanzapine and other coadjuvant medication
in both groups of follow up. To collect data
regarding treatment-derived adverse events,
changes in vital signs, laboratory analyses, and to measure the severity of possible extrapyramidal symptoms.
The Simpson Angus Scale, Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale (AIMS) will be used to assess the latter.
To determine the impact on resource utilization
the two treatment groups have. Direct costs derived
from hospital admissions, emergency room visits,
out-patient visits, home healthcare supports, as well as indirect costs derived from days out of work,
the patient's economic income, impact on the caregiver will also be quantified.
To assess the differences between groups
with respect to improvement in functioning and quality of life. The SF 36 Scale (the 36-Item Social Function Scale) will be applied.
To understand the degree of impact the illness provokes in relatives or caregivers
throughout the study. The self-report scale of
family burden (Escala de Carga Familiar - ECF) will be used for this purpose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2004
- Study completionMar 2006
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.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191997
- Sponsor's protocol ID
- 8834
- Other IDs
- F1D-XM-HGLW
- Status last verified
- Jul 2006
- First submitted
- 12 Sep 2005
- Last updated
- 25 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Treatment Duration With Olanzapine Following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies.
- ClinicalTrials.gov ID
- NCT00191997
- Acronym / sponsor ID
- 8834
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Mar 2006
- First posted
- 19 Sep 2005 (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 is a randomized, parallel, open-label study of patients who have responded to treatment in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the time of enrollment into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients, male or female, at least 18 years old
- Patient or legal representative must understand the study and sign an informed consent document before any study procedure
- Must have a diagnosis of Bipolar Disorder type I and have a recent manic or mixed episode, with or without hospitalization, according to DSM-IV-TR criteria.
- Patients must be in syndromic and symptomatic remission, following DSM-IV-IR criteria, for the manic or mixed episode, at the time of study entry, with a total score for YMRS less than or equal to 12 and total store for HAMD less than or equal to 8 at visit 1 and 2.
- Remission must have been achieved taking olanzapine in mono or co-therapy, and it must have been maintained until study entry.
Key exclusion criteria (6 listed)
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry, or with a study drug in other clinical trial
- Patients without symptoms or manic or mixed episode within one month of study entry.
- Confirmed diagnoses of Schizophrenia or other psychotic disorders (schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, substance-induced or medical condition psychotic disorder, psychotic disorder NOS),following DSM-IV-TR criteria.
- Patients that have achieved remission with ECT (electro convulsive therapy) in addition to psychopharmacological treatment
- Drug dependence or abuse, if it is a primary diagnose and the mood disorder is due to his administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine | Drug | – |
Primary outcome
The main objective of this study is to compare the efficacy in the prevention of relapse to manic, depressive, or
mixed episodes in two groups of bipolar I patients
who responded to open-label treatment with olanzapine in mono or co-therapy and who are in symptomatic and syndromic remission at the time of entering the study.
The first group will receive olanzapine for a period of
3 months following inclusion into the study; the second group will receive olanzapine for 12 months.
Relapses will be evaluated in terms of the total YMRS
(Young Mania Rating Scale) and HAMD-21 (the 21-item Hamilton Depression Rating Scale) scores.
28 secondary outcomes
The secondary objectives posed by this study are the following:
To compare the efficacy of maintaining olanzapine for 3 months versus maintaining it for 12 months in
the improvement of symptomatology in patients who had achieved remission. To this end, the reductions
on the total YMRS score, YMRS specific non-psychotic
item scores, HAMD 21 total score, the scores on the
HAMD 21 specific mood-related items, the total and
positive scores on the BPRS (Brief Psychiatric Rating Scale), and the CGI BP S(Clinical Global Impression of Severity) with respect to baseline will be evaluated.
DSM IV TR criteria will be used for manic and
depressive episodes in order to assess syndromic improvement.
To compare the efficacy of long-term treatments by means of longitudinal assessment using the
general subscale of the CGI BP M (Clinical Global Impression - Modified) and proceeding to
intra- and intergroup analyses.
To evaluate the safety of maintenance treatment
with olanzapine and other coadjuvant medication
in both groups of follow up. To collect data
regarding treatment-derived adverse events,
changes in vital signs, laboratory analyses, and to measure the severity of possible extrapyramidal symptoms.
The Simpson Angus Scale, Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale (AIMS) will be used to assess the latter.
To determine the impact on resource utilization
the two treatment groups have. Direct costs derived
from hospital admissions, emergency room visits,
out-patient visits, home healthcare supports, as well as indirect costs derived from days out of work,
the patient's economic income, impact on the caregiver will also be quantified.
To assess the differences between groups
with respect to improvement in functioning and quality of life. The SF 36 Scale (the 36-Item Social Function Scale) will be applied.
To understand the degree of impact the illness provokes in relatives or caregivers
throughout the study. The self-report scale of
family burden (Escala de Carga Familiar - ECF) will be used for this purpose.
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 25 Jul 2006.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine in people with Bipolar Disorder, run by Eli Lilly and Company at 11 sites in Spain.
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 6 inclusion and 6 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 25 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The main objective of this study is to compare the efficacy in the prevention of relapse to manic, depressive, or. The study lists 7 primary outcomes in all. 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 25 Jul 2006.