Bipolar DisorderPhase 4NCT00034580
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
A Phase 4 study testing olanzapine and risperidone in people with Bipolar Disorder, run by Eli Lilly and Company at 21 sites in United States.
Trial summary
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- olanzapine and risperidone
- How many people
- 326 participants
- Where
- 21 sitesUnited States
- Study dates
- Aug 2001to Aug 2002
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject, 18-70 years of age
- Female subjects of childbearing potential must be using a medically accepted means of contraception
- Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
- Subjects must be considered reliable
Who cannot join
- Female subjects who are either pregnant or nursing
- Uncorrected hypothyroidism or hyperthyroidism
- Narrow-angle glaucoma
- Subjects who present a serious and immediate risk of endangering him or herself
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Berkley, California
Study site
Boise, Idaho
Study site
Clementon, New Jersey
Study site
Denver, Colorado
Study site
Hoffman Estates, Illinois
Study site
Houston, Texas
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Madison, Tennessee
Study site
Middleton, Connecticut
Study site
Natick, Massachusetts
Study site
Olean, New York
Study site
Orange, California
Study site
Philadelphia, Pennsylvania
Study site
Richmond, Virginia
Study site
Roanoke, Virginia
Study site
San Marcos, California
Study site
St Louis, Missouri
Study site
Torrance, California
Study site
Washington D.C., District of Columbia
Study site
Winter Park, Florida
About this study
Official title: Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
- Conditions
- Bipolar Disorder
- Being tested
- olanzapine, risperidone
- Keywords
- Bipolar I Disorder
- 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
risperidoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2002 (estimated)
- Study startAug 2001
- Study completionAug 2002
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
- Double blind
- Enrolment
- 326 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034580
- Sponsor's protocol ID
- 5528
- Other IDs
- F1D-US-HGJT
- Status last verified
- Jul 2006
- First submitted
- 30 Apr 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
- ClinicalTrials.gov ID
- NCT00034580
- Acronym / sponsor ID
- 5528
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Aug 2002
- First posted
- 1 May 2002 (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 research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject, 18-70 years of age
- Female subjects of childbearing potential must be using a medically accepted means of contraception
- Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
- Subjects must be considered reliable
Key exclusion criteria (4 listed)
- Female subjects who are either pregnant or nursing
- Uncorrected hypothyroidism or hyperthyroidism
- Narrow-angle glaucoma
- Subjects who present a serious and immediate risk of endangering him or herself
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 | – |
| risperidone | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jul 2006.
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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.
21 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 and risperidone in people with Bipolar Disorder, run by Eli Lilly and Company at 21 sites in United States.
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 4 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 19 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 21 sites in United States. 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.
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 19 Jul 2006.