SchizophreniaPhase 4NCT00090012
Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder
A Phase 4 study testing Olanzapine and Quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 25 sites in United States.
Trial summary
The purposes of this study are to determine: The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight. The safety of olanzapine as compared to quetiapine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Olanzapine and Quetiapine
- How many people
- 340 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder
- You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period
Who cannot join
- You are a woman and are pregnant or breastfeeding
- You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.)
- You have a history of allergic reaction or intolerance to olanzapine or quetiapine
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baltimore, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brooklyn, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Clementon, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cleveland, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Conroe, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Detroit, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden Grove, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Granite City, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kenilworth, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Mesa, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lafayette, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lake Charles, Louisiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miami, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashua, New Hampshire
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Neptune City, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New York, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Olean, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Omaha, Nebraska
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paoli, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Princeton, New Jersey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rochester, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Springfield, Oregon
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Waco, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Washington D.C., District of Columbia
About this study
Official title: The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder
The purposes of this study are to determine:
- The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight.
- The safety of olanzapine as compared to quetiapine.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Olanzapine, Quetiapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
QuetiapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients
with schizophrenia or schizoaffective disorder. Relapse is defined as the occurrence of at least one of the following three conditions:
Hospitalization for psychiatric reasons after Visit 2, or
20% worsening on the Positive and Negative Syndrome Sale (PANSS) Total and an increase in level of care, as compared to Visit 2, or
20% worsening on the PANSS Total compared to Visit 2 and worsening of CGI-S by at least one level compared to Visit 2 and CGI-S level of at least 4 (moderately ill).
Secondary outcomes (16)
To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin
To assess within and between group changes in weight, waist circumference, BMI, appetite, and prevalence of patients meeting criteria for the metabolic syndrome
To assess within and between group changes in metabolic parameters (fasting glucose and lipids, and hemoglobin A1c) in a sub-group of patients with pre-existing diabetes prior to study entry
To assess the effect of olanzapine versus quetiapine on time to discontinuation for any reason, or lack of efficacy or worsening of psychiatric syndromes
To assess the efficacy of olanzapine versus quetiapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS and the Clinical Global Impression-Severity (CGI-S)
Scale as well as by absolute score of CGI-I (Improvement Scale)
To assess the efficacy of olanzapine versus quetiapine in improving depressive symptoms as measured by a mean change from baseline on the montgomery-Asberg Depression Rating Scale (MADRS)
To assess the efficacy of olanzapine versus quetiapine in improving patients' general well being and overall level of functioning as measured by the Short Form 36 Health Survey (SF-36), the Patient Global Impression (PGI)Scale,
and the Global Assessment of Functioning (GAF) Scale
To assess patients' opinions on the treatment with olanzapine versus quetiapine as measured by the Drug Attitude Inventory (DAI-10) Scale
To compare the utilization of medical resources between patients treated with olanzapine or quetiapine
To assess the safety of olanzapine and quetiapine as determined by:
Treatment-emergent adverse events
Vital signs and fasting laboratory analytes
Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the primary objective respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2004 (estimated)
- Study startJul 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 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
- 340 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
- NCT00090012
- Sponsor's protocol ID
- 8894
- Other IDs
- F1D-US-HGLR
- Status last verified
- Nov 2007
- First submitted
- 18 Aug 2004
- Last updated
- 6 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00090012
- Acronym / sponsor ID
- 8894
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 23 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.
The purposes of this study are to determine:
- The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight.
- The safety of olanzapine as compared to quetiapine.
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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder
- You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period
Key exclusion criteria (3 listed)
- You are a woman and are pregnant or breastfeeding
- You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.)
- You have a history of allergic reaction or intolerance to olanzapine or quetiapine
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 | – |
| Quetiapine | Drug | – |
Primary outcome
The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients
with schizophrenia or schizoaffective disorder. Relapse is defined as the occurrence of at least one of the following three conditions:
Hospitalization for psychiatric reasons after Visit 2, or
20% worsening on the Positive and Negative Syndrome Sale (PANSS) Total and an increase in level of care, as compared to Visit 2, or
20% worsening on the PANSS Total compared to Visit 2 and worsening of CGI-S by at least one level compared to Visit 2 and CGI-S level of at least 4 (moderately ill).
16 secondary outcomes
To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin
To assess within and between group changes in weight, waist circumference, BMI, appetite, and prevalence of patients meeting criteria for the metabolic syndrome
To assess within and between group changes in metabolic parameters (fasting glucose and lipids, and hemoglobin A1c) in a sub-group of patients with pre-existing diabetes prior to study entry
To assess the effect of olanzapine versus quetiapine on time to discontinuation for any reason, or lack of efficacy or worsening of psychiatric syndromes
To assess the efficacy of olanzapine versus quetiapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS and the Clinical Global Impression-Severity (CGI-S)
Scale as well as by absolute score of CGI-I (Improvement Scale)
To assess the efficacy of olanzapine versus quetiapine in improving depressive symptoms as measured by a mean change from baseline on the montgomery-Asberg Depression Rating Scale (MADRS)
To assess the efficacy of olanzapine versus quetiapine in improving patients' general well being and overall level of functioning as measured by the Short Form 36 Health Survey (SF-36), the Patient Global Impression (PGI)Scale,
and the Global Assessment of Functioning (GAF) Scale
To assess patients' opinions on the treatment with olanzapine versus quetiapine as measured by the Drug Attitude Inventory (DAI-10) Scale
To compare the utilization of medical resources between patients treated with olanzapine or quetiapine
To assess the safety of olanzapine and quetiapine as determined by:
Treatment-emergent adverse events
Vital signs and fasting laboratory analytes
Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the primary objective respectively
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 6 Nov 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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
25 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 Quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 25 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 2 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 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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.
What does the primary outcome measure?
The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients. The study lists 5 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 6 Nov 2007.