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Also known as LY170053, RAIM, olanzapine
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...
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Rapid Acting Intramuscular Olanzapine is an investigational small molecule being developed by Eli Lilly and Company for schizophrenia. It is a rapid acting intramuscular formulation, meaning it is administered by injection into the muscle. It is in Phase 3 clinical development.
Rapid Acting Intramuscular Olanzapine is being studied for the treatment of schizophrenia. The clinical trials have enrolled patients with schizophrenia, including agitated patients with schizophrenia. It is not yet approved and remains an investigational therapy in Phase 3 development.
Rapid Acting Intramuscular Olanzapine is being developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly is the sponsor of the Phase 3 clinical trials evaluating this intramuscular formulation in patients with schizophrenia.
Rapid Acting Intramuscular Olanzapine is in Phase 3 clinical development. Two Phase 3 trials have been completed, and there are currently no active trials. It is an investigational therapy and has not been approved by the FDA.
Rapid Acting Intramuscular Olanzapine has been evaluated in two completed Phase 3 trials: NCT00970281, a study of olanzapine in patients with schizophrenia, and NCT00640510, which compared rapid acting intramuscular olanzapine and placebo in agitated patients with schizophrenia. Both trials were conducted in Japan.
Yes, Rapid Acting Intramuscular Olanzapine and Rapid-Acting Intramuscular Olanzapine refer to the same investigational therapy. The difference is only in hyphenation and capitalization. Both names describe the same Eli Lilly small molecule in Phase 3 development for schizophrenia.