Bipolar DisorderPhase 4NCT00094549
Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder
A Phase 4 study testing olanzapine and divalproex sodium in people with Bipolar Disorder, run by Eli Lilly and Company at 42 sites in 5 countries.
Trial summary
The goals of this study are: A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania. B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- olanzapine and divalproex sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 42 sitesin 5 countries
- Study dates
- Oct 2004to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You must be 18 to 65 years old.
- You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
- You must be able to visit the doctor's office as scheduled for 15 weeks.
- All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
Who cannot join
- You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
- You are pregnant or breastfeeding
- You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.
Trial locations and contacts
42 sites in 5 countries.
42 sites in 5 countries
United States31 sites
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Austin, Texas, 78756
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Baltimore, Maryland, 21285
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Bellevue, Washington, 98004
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Beverly Hills, California, 90211
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Boyton Beach, Florida, 33426
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Brooklyn, New York, 11223
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Buffalo, New York, 14215
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Charleston, West Virginia, 25301
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Charlottesville, Virginia, 22903
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Chicago, Illinois, 60631
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Costa Mesa, California, 92626
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Dallas, Texas, 74234
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Decatur, Georgia, 30033
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DeLand, Florida, 32720
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Eagle, Idaho, 83616
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Escondido, California, 92025
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Joliet, Illinois, 60435
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Marietta, Georgia, 30060
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Media, Pennsylvania, 19063
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Memphis, Tennessee, 38119
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North Miami, Florida, 33161
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Oklahoma City, Oklahoma, 73120
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Orange, California, 92868
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Pico Rivera, California, 90660
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Rochester, New York, 14624
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San Diego, California, 92108
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Scottsdale, Arizona, 85251
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Tampa, Florida, 33613
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Virginia Beach, Virginia, 23452
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Washington D.C., District of Columbia, 20016
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Wichita, Kansas, 67207
Lithuania4 sites
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Klaipėda, 91251
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Šiauliai, 76231
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Vilnius, 11205
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Ziegzdriu K, 53136
Russia3 sites
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Lipetsk, 399007
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Moscow, 107076
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Saint Petersburg, 190021
Puerto Rico2 sites
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Caguas, 00725
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Ponce, 00731
Romania2 sites
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Bucharest, 050042
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Târgu Mureş, 540139
About this study
Official title: Olanzapine Versus Divalproex and Placebo in the Treatment of Mild to Moderate Mania Associated With Bipolar I Disorder
The goals of this study are:
- To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.
- To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.
- To assess how olanzapine compares to divalproex.
- Conditions
- Bipolar Disorder
- Being tested
- olanzapine, divalproex sodium, placebo
- 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
divalproex sodiumDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate
mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).
Secondary outcomes (31)
Treatment comparison for the reductions of the YMRS total score from baseline to the endpoint of Study Period II: Assess the superiority of olanzapine compared to placebo;
Assess the superiority of divalproex compared to placebo;
In the event that olanzapine vs. divalproex comparison is not significant, and that divalproex is superior to placebo, an assessment of non-inferiority of olanzapine compared with divalproex will be performed
Assess the acute efficacy of olanzapine compared with divalproex and placebo in improving clinical symptomatology during Study Period II, using several measures: Rate of response, with response defined as reduction of
50% or more in the YMRS total score at the endpoint of Study Period II; Time to response, with time to response defined as the time in days from first dose at which a reduction of 50% or more in the YMRS total score is first
observed
given that a response is achieved at the endpoint of Study Period II;
Rate of remission of mania, with remission defined as a YMRS total score of less than or equal to 12 at endpoint of Study Period II; Time to remission of mania, with time to remission defined as the time in days from first
dose at which a YMRS total score of less than or equal to 12 is first observed given that remission is achieved at the endpoint of Study Period II; Reductions from baseline to endpoint of Study Period II on the
Montgomery-Asberg Depression Rating Scale (MADRS) total score and the Clinical Global Impressions-Bipolar Version Severity of Illness (CGI-BP Severity) score
Assess the longer-term efficacy of olanzapine compared with divalproex during Study Period III, using several measures: Reductions in the YMRS, MADRS, and CGI-BP scores from the endpoint of Study Period II to the
endpoint of Study Period III; Rate of failure to maintain response during Study Period III, as measured by a return to a YMRS total score greater than or equal to 20 AND/OR hospitalization due to deterioration in clinical
symptoms of mania at any Study Period III visit, among patients who had achieved response by the endpoint of Study Period II; Time to failure to maintain response during Study Period III, as measured by the time
in days from the endpoint of Study Period II to a return to a YMRS total score greater than or equal to 20 AND/OR hospitalization due to deterioration in clinical symptoms of mania, among patients who had achieved
response by the endpoint of Study Period II; Rate of relapse of mania, where relapse is defined as achieving a YMRS total score greater than or equal to 15 AND/OR hospitalization due to deterioration in clinical symptoms
of mania, at any Study Period III visit, among patients who had achieved remission at the endpoint of Study Period II; Time to relapse of mania, as measured by the time in days from the endpoint of Study Period II to a
return to a YMRS total score greater than or equal to 15 AND/OR hospitalization due to deterioration in clinical symptoms of mania, among patients who had achieved remission at the endpoint of Study Period II
Assess the Treatment by Subgroup interaction of Manic vs. Mixed, as defined by DSM-IV (as assessed by the Clinician's Version of the Structured Clinical Interview for DSM-IV [SCID-CV]), during both Study Period II and
Study Period III for efficacy variables of YMRS and CGI-BP
Assess the rate of switch to a depressive episode in patients not depressed at baseline (MADRS score less than or equal to 12, with a depressive episode defined as a MADRS score greater than or equal to 16 OR
hospitalization due to deterioration in clinical symptoms of depression
Assess the safety of olanzapine compared with divalproex and placebo during Study Period II, and to assess the safety of olanzapine compared with divalproex during Study Period III; Safety evaluations will include
assessment of treatment-emergent adverse events, vital signs and weight, laboratory evaluations, electrocardiograms (ECGs), and extrapyramidal symptoms as assessed using the Barnes Akathisia Scale (Barnes),
Abnormal Involuntary Movement Scale (AIMS), and Simpson-Angus Scale
Evaluate functional status and health-related quality of life associated with olanzapine compared with divalproex as measured by change from baseline to endpoints of Study Period II and Study Period III in
the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)total score and subscale total scores
Evaluate the level of health resource utilization and resource utilization costs associated with olanzapine compared with divalproex during Study Periods II and III (up to 12 weeks of therapy) using the
Resource Utilization
Assess the rate of hospitalization of patients on olanzapine compared with patients on divalproex during Study Periods II and III (up to 12 weeks of therapy) using the Hospitalization Inventory
Evaluate psychosocial outcomes associated with olanzapine compared with divalproex as measured by change from baseline to endpoints of Study Period II and Study Period III on the Streamlined Longitudinal
Interview Clinical Evaluation from the Longitudinal Interval Follow-up Evaluation (SLICE/LIFE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2004 (estimated)
- Study startOct 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call1-877-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
- NCT00094549
- Sponsor's protocol ID
- 7029
- Other IDs
- F1D-MC-HGKQ
- Status last verified
- Jan 2007
- First submitted
- 20 Oct 2004
- Last updated
- 26 Jan 2007
- Results posted
- No
Publications
Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
PubMed 22967772Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
PubMed 21095016Tohen M, Vieta E, Goodwin GM, Sun B, Amsterdam JD, Banov M, Shekhar A, Aaronson ST, Bardenstein L, Grecu-Gabos I, Tochilov V, Prelipceanu D, Oliff HS, Kryzhanovskaya L, Bowden C. Olanzapine versus divalproex versus placebo in the treatment of mild to moderate mania: a randomized, 12-week, double-blind study. J Clin Psychiatry. 2008 Nov;69(11):1776-89. doi: 10.4088/jcp.v69n1113. Epub 2008 Oct 7.
PubMed 19014751
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine Versus Divalproex and Placebo in the Treatment of Mild to Moderate Mania Associated With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00094549
- Acronym / sponsor ID
- 7029
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Dec 2006
- First posted
- 21 Oct 2004 (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.
The goals of this study are:
- To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.
- To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.
- To assess how olanzapine compares to divalproex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- You must be 18 to 65 years old.
- You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
- You must be able to visit the doctor's office as scheduled for 15 weeks.
- All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
Key exclusion criteria (3 listed)
- You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
- You are pregnant or breastfeeding
- You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.
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 | – |
| divalproex sodium | Drug | – |
| placebo | Drug | – |
Primary outcome
To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate
mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).
31 secondary outcomes
Treatment comparison for the reductions of the YMRS total score from baseline to the endpoint of Study Period II: Assess the superiority of olanzapine compared to placebo;
Assess the superiority of divalproex compared to placebo;
In the event that olanzapine vs. divalproex comparison is not significant, and that divalproex is superior to placebo, an assessment of non-inferiority of olanzapine compared with divalproex will be performed
Assess the acute efficacy of olanzapine compared with divalproex and placebo in improving clinical symptomatology during Study Period II, using several measures: Rate of response, with response defined as reduction of
50% or more in the YMRS total score at the endpoint of Study Period II; Time to response, with time to response defined as the time in days from first dose at which a reduction of 50% or more in the YMRS total score is first
observed
given that a response is achieved at the endpoint of Study Period II;
Rate of remission of mania, with remission defined as a YMRS total score of less than or equal to 12 at endpoint of Study Period II; Time to remission of mania, with time to remission defined as the time in days from first
dose at which a YMRS total score of less than or equal to 12 is first observed given that remission is achieved at the endpoint of Study Period II; Reductions from baseline to endpoint of Study Period II on the
Montgomery-Asberg Depression Rating Scale (MADRS) total score and the Clinical Global Impressions-Bipolar Version Severity of Illness (CGI-BP Severity) score
Assess the longer-term efficacy of olanzapine compared with divalproex during Study Period III, using several measures: Reductions in the YMRS, MADRS, and CGI-BP scores from the endpoint of Study Period II to the
endpoint of Study Period III; Rate of failure to maintain response during Study Period III, as measured by a return to a YMRS total score greater than or equal to 20 AND/OR hospitalization due to deterioration in clinical
symptoms of mania at any Study Period III visit, among patients who had achieved response by the endpoint of Study Period II; Time to failure to maintain response during Study Period III, as measured by the time
in days from the endpoint of Study Period II to a return to a YMRS total score greater than or equal to 20 AND/OR hospitalization due to deterioration in clinical symptoms of mania, among patients who had achieved
response by the endpoint of Study Period II; Rate of relapse of mania, where relapse is defined as achieving a YMRS total score greater than or equal to 15 AND/OR hospitalization due to deterioration in clinical symptoms
of mania, at any Study Period III visit, among patients who had achieved remission at the endpoint of Study Period II; Time to relapse of mania, as measured by the time in days from the endpoint of Study Period II to a
return to a YMRS total score greater than or equal to 15 AND/OR hospitalization due to deterioration in clinical symptoms of mania, among patients who had achieved remission at the endpoint of Study Period II
Assess the Treatment by Subgroup interaction of Manic vs. Mixed, as defined by DSM-IV (as assessed by the Clinician's Version of the Structured Clinical Interview for DSM-IV [SCID-CV]), during both Study Period II and
Study Period III for efficacy variables of YMRS and CGI-BP
Assess the rate of switch to a depressive episode in patients not depressed at baseline (MADRS score less than or equal to 12, with a depressive episode defined as a MADRS score greater than or equal to 16 OR
hospitalization due to deterioration in clinical symptoms of depression
Assess the safety of olanzapine compared with divalproex and placebo during Study Period II, and to assess the safety of olanzapine compared with divalproex during Study Period III; Safety evaluations will include
assessment of treatment-emergent adverse events, vital signs and weight, laboratory evaluations, electrocardiograms (ECGs), and extrapyramidal symptoms as assessed using the Barnes Akathisia Scale (Barnes),
Abnormal Involuntary Movement Scale (AIMS), and Simpson-Angus Scale
Evaluate functional status and health-related quality of life associated with olanzapine compared with divalproex as measured by change from baseline to endpoints of Study Period II and Study Period III in
the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)total score and subscale total scores
Evaluate the level of health resource utilization and resource utilization costs associated with olanzapine compared with divalproex during Study Periods II and III (up to 12 weeks of therapy) using the
Resource Utilization
Assess the rate of hospitalization of patients on olanzapine compared with patients on divalproex during Study Periods II and III (up to 12 weeks of therapy) using the Hospitalization Inventory
Evaluate psychosocial outcomes associated with olanzapine compared with divalproex as measured by change from baseline to endpoints of Study Period II and Study Period III on the Streamlined Longitudinal
Interview Clinical Evaluation from the Longitudinal Interval Follow-up Evaluation (SLICE/LIFE)
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 26 Jan 2007.
- Derived from this study: PubMed 22967772Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
- Derived from this study: PubMed 21095016Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
- Derived from this study: PubMed 19014751Tohen M, Vieta E, Goodwin GM, Sun B, Amsterdam JD, Banov M, Shekhar A, Aaronson ST, Bardenstein L, Grecu-Gabos I, Tochilov V, Prelipceanu D, Oliff HS, Kryzhanovskaya L, Bowden C. Olanzapine versus divalproex versus placebo in the treatment of mild to moderate mania: a randomized, 12-week, double-blind study. J Clin Psychiatry. 2008 Nov;69(11):1776-89. doi: 10.4088/jcp.v69n1113. Epub 2008 Oct 7.
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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.
Call1-877-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
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olanzapine and divalproex sodium in people with Bipolar Disorder, run by Eli Lilly and Company at 42 sites in 5 countries.
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 4 inclusion and 3 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 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Lithuania, Russia, Puerto Rico, Romania. 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?
To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094549, which also lists 3 linked publications.
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 26 Jan 2007.