SchizophreniaPhase 1/2NCT00089869
A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia
A Phase 1/2 study testing olanzapine and atomoxetine in people with Schizophrenia, run by Eli Lilly and Company at 20 sites in United States.
Trial summary
Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdal, Seroquel, Zyprexa Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- olanzapine and atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 20 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have a clinical diagnosis of Schizophrenia
- Must be at least 18 years of age and not older than 55 years of age
- Must have been stable on a dose of Abilify, Risperdal, Seroquel, or Zyprexa for the past 8 weeks
- Women of childbearing potential must be using a medically accepted means of contraception
- Must be able to swallow capsules
Who cannot join
- Has serious health problems other than Schizophrenia
- Takes an antidepressant for depression
- Takes insulin for diabetes
- Have a history of alcohol or drug dependence (except for nicotine and caffeine) within the past 6 months
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Atlanta, Georgia
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Austin, Texas
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Butner, North Carolina
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Cerritos, California
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Chapel Hill, North Carolina
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Chicago, Illinois
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician.
Chula Vista, California
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Garden Grove, California
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Indianapolis, Indiana
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Iowa City, Iowa
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Irving, Texas
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Irving, Texas
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Lebanon, New Hampshire
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Minneapolis, Minnesota
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
New Haven, Connecticut
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
New Haven, Connecticut
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
New York, New York
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
Okalahoma City, Oklahoma
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
San Antonio, Texas
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician."
San Diego, California
About this study
Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdal, Seroquel, Zyprexa
- Conditions
- Schizophrenia
- Being tested
- olanzapine, atomoxetine, placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
atomoxetineDrug
placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089869
- Sponsor's protocol ID
- 8269
- Other IDs
- H6U-MC-HGLM
- Status last verified
- Jul 2006
- First submitted
- 16 Aug 2004
- Last updated
- 20 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT00089869
- Acronym / sponsor ID
- 8269
- Conditions
- Schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 18 Aug 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.
Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdal, Seroquel, Zyprexa
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have a clinical diagnosis of Schizophrenia
- Must be at least 18 years of age and not older than 55 years of age
- Must have been stable on a dose of Abilify, Risperdal, Seroquel, or Zyprexa for the past 8 weeks
- Women of childbearing potential must be using a medically accepted means of contraception
- Must be able to swallow capsules
Key exclusion criteria (4 listed)
- Has serious health problems other than Schizophrenia
- Takes an antidepressant for depression
- Takes insulin for diabetes
- Have a history of alcohol or drug dependence (except for nicotine and caffeine) within the past 6 months
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 | – |
| atomoxetine | Drug | – |
| placebo | 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 20 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing olanzapine and atomoxetine in people with Schizophrenia, run by Eli Lilly and Company at 20 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 5 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 20 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 20 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Jul 2006.