SchizophreniaPhase 4NCT00103571
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
A Phase 4 study testing Olanzapine and Aripiprazole in people with Schizophrenia, run by Eli Lilly and Company at 5 sites in 2 countries.
Trial summary
The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder. 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 Aripiprazole
- How many people
- 600 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2004to Aug 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Patients must be agitated
- Patients must display psychotic symptoms
- Patients must be inpatients who are expected to stay in the hospital for at least 5 days
- Patients must be 18 to 55 years of age
Who cannot join
- Patients may not be hospitalized for greater than 72 hours prior to study start
- Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
- Patients may not be actively suicidal
- Patients may not be diagnosed with substance-induced psychosis or substance dependence
- Patients may not have acute, serious, or unstable medical conditions
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Beachwood, Ohio, 44122
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Canton, Ohio, 44708
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Memphis, Tennessee, 38117
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Saint Charles, Missouri, 63301
Puerto Rico1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Rio Piedras, 00926
About this study
The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
AripiprazoleDrug
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 test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the
Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and
aripiprazole in reducing agitation.
Secondary outcomes (18)
The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
the PANSS_EC from baseline;
The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
of Nursing Intervention
The proportion of patients using pm lorazepam and the time-course of usage.
The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
of psychiatric illness.
Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
primary objective respectively.
Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
days in the treatment of acutely ill patients with schizophrenia as assessed by:
Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
Review of spontaneous (unsolicited) treatment emergent adverse events;
Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2005 (estimated)
- Study startJul 2004
- Study completionAug 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
- 600 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-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
- NCT00103571
- Sponsor's protocol ID
- 8928
- Other IDs
- F1D-US-HGLS
- Status last verified
- Nov 2007
- First submitted
- 10 Feb 2005
- 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
- Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00103571
- Acronym / sponsor ID
- 8928
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 11 Feb 2005 (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 assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Patients must be agitated
- Patients must display psychotic symptoms
- Patients must be inpatients who are expected to stay in the hospital for at least 5 days
- Patients must be 18 to 55 years of age
Key exclusion criteria (5 listed)
- Patients may not be hospitalized for greater than 72 hours prior to study start
- Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
- Patients may not be actively suicidal
- Patients may not be diagnosed with substance-induced psychosis or substance dependence
- Patients may not have acute, serious, or unstable medical conditions
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 | – |
| Aripiprazole | Drug | – |
Primary outcome
The primary objective of this study is to test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the
Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and
aripiprazole in reducing agitation.
18 secondary outcomes
The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
the PANSS_EC from baseline;
The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
of Nursing Intervention
The proportion of patients using pm lorazepam and the time-course of usage.
The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
of psychiatric illness.
Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
primary objective respectively.
Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
days in the treatment of acutely ill patients with schizophrenia as assessed by:
Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
Review of spontaneous (unsolicited) treatment emergent adverse events;
Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.
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.
Call 1-877-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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine and Aripiprazole in people with Schizophrenia, run by Eli Lilly and Company at 5 sites in 2 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 5 inclusion and 5 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 5 sites in United States, Puerto Rico. 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 test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the. The study lists 3 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.