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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00723606 | A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation | PHASE3 | COMPLETED | 376 | — | — | Sep 1, 2008 | Jul 1, 2009 | Mar 3, 2021 | 9 | China |
BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.
| Arm | Type | Description |
|---|---|---|
| Intramuscular ziprasidone | EXPERIMENTAL | - |
| Intramuscular haloperidol | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Intramuscular ziprasidone mesylate | DRUG | The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days. |
| Intramuscular haloperidol | DRUG | The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days. |
Inclusion Criteria: * Male or female Chinese subjects aged 18-65 years (including 65) at screening. * Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X). * Subjects who are in acute phase of schizophrenia and are appropriate to receive...