SchizophreniaPhase 4NCT00485498
Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics
A Phase 4 study testing Olanzapine Hydrochloride and Risperidone in people with Schizophrenia, run by Eli Lilly and Company at 1 site in China.
Trial summary
The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine Hydrochloride and Risperidone
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Apr 2003to Dec 2003
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects, aged 18 - 60
- Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
- Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
- BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
- Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications
Who cannot join
- Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
- Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
- Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
- Treatment with remoxipride within 6 months (180 days) prior to visit 1
- Documented history of allergic reaction to study medications
Trial locations and contacts
1 site in 1 country.
China1 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.
Beijing
About this study
Official title: Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone
The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine Hydrochloride, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine HydrochlorideDrug
RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose
Secondary outcomes (5)
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 3 days as measured by the BPRS-T, PANSS-P, ACES, CGI-I and CGI-S.
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the BPRS-T
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
To compare the change in severity of akathasia in schizophrenic patients between olanzapine and risperidone as measured by the BAS within the 6-week treatment period
To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startApr 2003
- Study completionDec 2003
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
- 122 participants (actual)
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
- NCT00485498
- Sponsor's protocol ID
- 6704
- Other IDs
- F1D-GH-S036
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 13 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone
- ClinicalTrials.gov ID
- NCT00485498
- Acronym / sponsor ID
- 6704
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Dec 2003 (actual)
- First posted
- 13 Jun 2007 (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 examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects, aged 18 - 60
- Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
- Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
- BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
- Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications
Key exclusion criteria (5 listed)
- Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
- Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
- Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
- Treatment with remoxipride within 6 months (180 days) prior to visit 1
- Documented history of allergic reaction to study medications
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 Hydrochloride | Drug | – |
| Risperidone | Drug | – |
Primary outcome
To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose
5 secondary outcomes
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 3 days as measured by the BPRS-T, PANSS-P, ACES, CGI-I and CGI-S.
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the BPRS-T
To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
To compare the change in severity of akathasia in schizophrenic patients between olanzapine and risperidone as measured by the BAS within the 6-week treatment period
To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS
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 13 Jun 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
1 site 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 Hydrochloride and Risperidone in people with Schizophrenia, run by Eli Lilly and Company at 1 site in China.
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 13 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose. 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 13 Jun 2007.