Acute AgitationPhase 3NCT05803642
A Study of Olanzapine in Patients With Acute Agitation
A Phase 3 study testing Olanzapine and Haloperidol in people with Acute Agitation, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Agitation
- What is being tested?
- Olanzapine and Haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2023to 2 Jul 2024
- 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 and female patients between the ages of 18 to 65 years, inclusive.
- Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.
- Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization.
Who cannot join
- Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.
- Patients who have had previous suicidal behavior or currently at serious risk of suicide.
- Patients with glaucoma or at risk of angle-closure glaucoma.
- Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia.
- Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.
- Treatment with psychostimulants or reserpine within one week before randomization.
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- Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval.
- Treatment with clozapine within 4 weeks before screening.
- Patients with serious or unstable medical illnesses.
- Female patients who have a positive pregnancy test at screening or are breastfeeding.
- Patients who have participated in other clinical trials within 3 months before randomization.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.
The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.
- Conditions
- Acute Agitation
- Being tested
- Olanzapine, Haloperidol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
intramuscular injection, 10 mg/dose, first dose and an optional second or third dose.
HaloperidolDrug
intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Not described Receives: Drug: Olanzapine |
| Haloperidol | Active comparator | Not described Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 2 hours post-first IM injection on the PANSS-EC
The PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 2 hours
Secondary outcomes (2)
Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score
Measured: 2 hours post-first IM injection
Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 Mar 2023 (estimated)
- Primary completion7 May 2024 (estimated)
- Study completion2 Jul 2024 (estimated)
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 Acute AgitationStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803642
- Sponsor's protocol ID
- QLG2072-301
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dong F, Wang Z, Li C, Li X, Zhu D, Li J, Wang Z, Gong J, Zhou J, Liu H, Zhang Y, Zhang X, Chen X, Yu M, Tan X, Qian M, Luo Y, Guo WJ, Xie S, Huang J, Zhao J, Wan J, Shan Y, Li N, Wang J, Ju Y, Wang J, Bian Q, Wang G. Intramuscular Generic Injection (QLG2072) versus Haloperidol in Chinese Patients with Acute Agitation: A Phase 3 Multicenter, Randomized, Double-Blind, Active-Controlled Trial. Drug Des Devel Ther. 2026 Feb 25;20:561494. doi: 10.2147/DDDT.S561494. eCollection 2026.
PubMed 41778148
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.
- ClinicalTrials.gov ID
- NCT05803642
- Acronym / sponsor ID
- QLG2072-301
- Conditions
- Acute Agitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (estimated)
- Primary completion
- 7 May 2024 (estimated)
- Study completion
- 2 Jul 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- 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 assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine |
| Haloperidol | Active comparator | Drug: Haloperidol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients between the ages of 18 to 65 years, inclusive.
- Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.
- Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization.
Key exclusion criteria (11 listed)
- Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.
- Patients who have had previous suicidal behavior or currently at serious risk of suicide.
- Patients with glaucoma or at risk of angle-closure glaucoma.
- Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia.
- Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.
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 |
|---|---|---|
| Olanzapineintramuscular injection, 10 mg/dose, first dose and an optional second or third dose. | Drug | Olanzapine |
| Haloperidolintramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose. | Drug | Haloperidol |
Primary outcome
Change from baseline to 2 hours post-first IM injection on the PANSS-EC
Time frame: 2 hours
The PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
2 secondary outcomes
Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score
Time frame: 2 hours post-first IM injection
Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 41778148Dong F, Wang Z, Li C, Li X, Zhu D, Li J, Wang Z, Gong J, Zhou J, Liu H, Zhang Y, Zhang X, Chen X, Yu M, Tan X, Qian M, Luo Y, Guo WJ, Xie S, Huang J, Zhao J, Wan J, Shan Y, Li N, Wang J, Ju Y, Wang J, Bian Q, Wang G. Intramuscular Generic Injection (QLG2072) versus Haloperidol in Chinese Patients with Acute Agitation: A Phase 3 Multicenter, Randomized, Double-Blind, Active-Controlled Trial. Drug Des Devel Ther. 2026 Feb 25;20:561494. doi: 10.2147/DDDT.S561494. eCollection 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine and Haloperidol in people with Acute Agitation, run by Qilu Pharmaceutical Co., Ltd..
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Wang, PhD (010-58303236, adwanggang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 2 hours post-first IM injection on the PANSS-EC (time frame: 2 hours). 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 NCT05803642, 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 7 Apr 2023.