Approval Probability
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ML Risk
Rapid Acting Intramuscular Olanzapine · 2 trials · 1 indication
Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.
Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.
| Arm | Type | Description |
|---|---|---|
| 10 mg Olanzapine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| IM olanzapine 10mg | EXPERIMENTAL | Patients will receive at least one injection of Intramuscular (IM) olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection). |
| IM placebo | PLACEBO_COMPARATOR | Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection). |
| Name | Type | Description |
|---|---|---|
| Rapid-Acting Intramuscular Olanzapine | DRUG | Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections |
| Placebo | DRUG | Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections |
| Rapid Acting Intramuscular Olanzapine | DRUG | 10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection). |
| Isotonic sodium chloride solution | DRUG | 0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection). |
Inclusion Criteria: * Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) criteria for schizophrenia. * Patients with an exacerbation of schizophrenia with acute psychotic agitation. * Patients who are hospitalized during the study. * Pat...
Rapid Acting Intramuscular Olanzapine is an investigational small molecule being developed for the treatment of schizophrenia. It is administered via intramuscular injection and is intended to address agitation in patients with schizophrenia. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Rapid Acting Intramuscular Olanzapine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for schizophrenia.
Rapid Acting Intramuscular Olanzapine is in Phase 3 clinical development. Two Phase 3 trials have been completed, both of which were randomized, double-blind, and placebo-controlled studies in patients with schizophrenia. The drug remains investigational and is not yet approved for commercial use.
Rapid Acting Intramuscular Olanzapine has been studied in two completed Phase 3 clinical trials. The first trial, NCT00640510, enrolled 34 patients and compared the drug to placebo in agitated patients with schizophrenia in Japan. The second trial, NCT00970281, enrolled 91 patients and evaluated olanzapine in patients with schizophrenia in Japan.
Rapid Acting Intramuscular Olanzapine is a formulation of olanzapine, an atypical antipsychotic, designed for rapid intramuscular administration. While the active ingredient is olanzapine, this specific formulation is being studied for its rapid onset of action in treating agitation associated with schizophrenia. It is not the same as oral olanzapine formulations.