SchizophreniaPhase 4NCT00036088
Olanzapine Versus An Active Comparator in the Treatment of Schizophrenia
A Phase 4 study testing Olanzapine in people with Schizophrenia, run by Eli Lilly and Company at 60 sites in 12 countries.
Trial summary
The purpose of this study is to determine how Olanzapine compares to an active comparator in the treatment of schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine
- How many people
- 530 participants
- Where
- 60 sitesin 12 countries
- Study dates
- Aug 2001to Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You must be between the ages of 18 and 75. If you have reached your 76th birthday, you will not be able to participate
- You must have been diagnosed with schizophrenia
- You must be able to visit the doctor's office as scheduled for the next 7 months
Who cannot join
- You have a serious medical illness, such as heart, liver, or kidney disease (Note: If you are uncertain about a particular condition, discuss it with your doctor.)
- You are either pregnant or breastfeeding
Trial locations and contacts
60 sites in 12 countries.
60 sites in 12 countries
United States25 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
El Centro, California
Study site
El Paso, Texas
Study site
Glendale, California
Study site
Hoffman Estates, Illinois
Study site
Houston, Texas
Study site
Lafayette, Indiana
Study site
Melbourne, Florida
Study site
Miami, Florida
Study site
Middleton, Connecticut
Study site
New York, New York
Study site
Newton, Massachusetts
Study site
Norwich, Connecticut
Study site
Olean, New York
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Richmond, Virginia
Study site
Rockville, Maryland
Study site
Saint Charles, Missouri
Study site
Sherman Oaks, California
Study site
Staten Island, New York
Study site
Terrell, Texas
Austria5 sites
Study site
Graz
Study site
Innsbruck
Study site
Linz
Study site
Wein
Study site
Wels
Brazil5 sites
Study site
Aparecida de Goiânia, Goiás
Study site
Pelotas, Rio Grande do Sul
Study site
Rio de Janeiro
Study site
Salvador, Estado de Bahia
Study site
Sau Paulo, Sau Paulo
Spain5 sites
Study site
Barcelona, Barcelona
Study site
Elizondo, Navarre
Study site
Langreo, Principality of Asturias
Study site
Pamplona, Navarre
Study site
San Boi de Llobregat, Barcelona
United Kingdom5 sites
Study site
Camberwell, London
Study site
Guildford, Surrey
Study site
Kings Lynn, Norfolk
Study site
London, London
Study site
Paisley, Scotland
Argentina4 sites
Study site
Buenos Aires
Study site
Ciudad de Buenos Air
Study site
Godoy Cruz, Mendoza Province
Study site
La Plata, Buenos Aires
Puerto Rico4 sites
Study site
Cidra
Study site
Ponce
Study site
Rio Piedras
Study site
San Juan
About this study
The purpose of this study is to determine how Olanzapine compares to an active comparator in the treatment of schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2002 (estimated)
- Study startAug 2001
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- 530 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036088
- Sponsor's protocol ID
- 2347
- Other IDs
- F1D-MC-HGHJ
- Status last verified
- Jul 2006
- First submitted
- 7 May 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Publications
Liu-Seifert H, Ascher-Svanum H, Osuntokun O, Jen KY, Gomez JC. Change in level of productivity in the treatment of schizophrenia with olanzapine or other antipsychotics. BMC Psychiatry. 2011 May 17;11:87. doi: 10.1186/1471-244X-11-87.
PubMed 21586165
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 An Active Comparator in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT00036088
- Acronym / sponsor ID
- 2347
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Jul 2002
- First posted
- 8 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.
The purpose of this study is to determine how Olanzapine compares to an active comparator in the treatment of schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- You must be between the ages of 18 and 75. If you have reached your 76th birthday, you will not be able to participate
- You must have been diagnosed with schizophrenia
- You must be able to visit the doctor's office as scheduled for the next 7 months
Key exclusion criteria (2 listed)
- You have a serious medical illness, such as heart, liver, or kidney disease (Note: If you are uncertain about a particular condition, discuss it with your doctor.)
- You are either pregnant or breastfeeding
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
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.
- Derived from this study: PubMed 21586165Liu-Seifert H, Ascher-Svanum H, Osuntokun O, Jen KY, Gomez JC. Change in level of productivity in the treatment of schizophrenia with olanzapine or other antipsychotics. BMC Psychiatry. 2011 May 17;11:87. doi: 10.1186/1471-244X-11-87.
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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.
60 sites in 12 countries: 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 Schizophrenia, run by Eli Lilly and Company at 60 sites in 12 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 3 inclusion and 2 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 60 sites in United States, Austria, Brazil, Spain, United Kingdom and 7 more countries. 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?
On the ClinicalTrials.gov record for NCT00036088, which also lists 1 linked publication.
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.