Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00970281 | A Study of Olanzapine in Patients With Schizophrenia | PHASE3 | COMPLETED | 91 | — | — | Sep 1, 2009 | Apr 1, 2011 | Mar 7, 2012 | 11 | Japan |
| NCT00640510 | A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia | PHASE3 | COMPLETED | 34 | — | — | Mar 1, 2008 | Jul 1, 2008 | Sep 2, 2009 | 11 | Japan |
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...