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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine | Experimental |
| |
| Haloperidol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | intramuscular injection, 10 mg/dose, first dose and an optional second or third dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score | 2 hours post-first IM injection | |
| Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Wang, PhD | Contact | 010-58303236 | adwanggang@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41778148 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Haloperidol | Drug | intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose. |
|
| D006571 | Heterocyclic Compounds |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |