SchizophreniaPhase 3NCT00485901
Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
A Phase 3 study testing Olanzapine Hydrochloride and Haloperidol in people with Schizophrenia, run by Eli Lilly and Company at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine Hydrochloride and Haloperidol
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2004to Jan 2005
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, between the ages of 18 and 65
- Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
- Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
- Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
- Patient must be hospitalized during the study
Who cannot join
- Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
- Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
- Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
- Documented history of allergic reaction to study medication(s)
- Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
Trial locations and contacts
1 site in 1 country.
Taiwan1 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.
Taipei
About this study
Official title: A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia
The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Olanzapine Hydrochloride, Haloperidol
- 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
HaloperidolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection
Secondary outcomes (3)
Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study
Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection
Compare the response rates and time to response during the 2 hours post-first IM injection.
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 startJul 2004
- Study completionJan 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 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
- NCT00485901
- Sponsor's protocol ID
- 6409
- Other IDs
- F1D-TW-S025
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 13 Jun 2007
- Results posted
- No
Publications
Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
PubMed 38958149
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
- A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00485901
- Acronym / sponsor ID
- 6409
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Jan 2005 (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 compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, between the ages of 18 and 65
- Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
- Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
- Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
- Patient must be hospitalized during the study
Key exclusion criteria (5 listed)
- Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
- Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
- Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
- Documented history of allergic reaction to study medication(s)
- Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
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 | – |
| Haloperidol | Drug | – |
Primary outcome
Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection
3 secondary outcomes
Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study
Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection
Compare the response rates and time to response during the 2 hours post-first IM injection.
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.
- Derived from this study: PubMed 38958149Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
- 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 3 study testing Olanzapine Hydrochloride and Haloperidol in people with Schizophrenia, run by Eli Lilly and Company at 1 site in Taiwan.
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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00485901, 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 13 Jun 2007.