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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00645372 | A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients | PHASE3 | COMPLETED | 242 | — | — | Jul 1, 2004 | May 1, 2005 | Feb 21, 2021 | 5 | China |
| NCT00143351 | Mozart Relapse Study | PHASE3 | COMPLETED | 75 | — | — | Jun 1, 2003 | Sep 1, 2005 | Feb 21, 2021 | 16 | Italy |
| NCT00136994 | IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study) | PHASE3 | COMPLETED | 160 | — | — | Mar 1, 2003 | Nov 1, 2005 | Feb 21, 2021 | 34 | Italy |
| NCT00649844 | A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs | PHASE3 | COMPLETED | 147 | — | — | Jan 1, 2003 | Sep 1, 2004 | Feb 21, 2021 | 22 | Italy |
| NCT00139737 | Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia | PHASE3 | COMPLETED | 344 | — | — | Mar 1, 2002 | Jun 1, 2009 | Mar 3, 2021 | 87 | Italy |
| NCT00174447 | Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031 | PHASE3 | COMPLETED | 43 | — | — | Oct 1, 2001 | Oct 1, 2008 | Mar 24, 2021 | 14 | France |
| NCT00650611 | A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders | PHASE2 | COMPLETED | 63 | — | — | Dec 1, 2003 | Mar 1, 2005 | Feb 21, 2021 | 17 | United States |
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| A1 | EXPERIMENTAL | - |
| Low-Dose Ziprasidone | ACTIVE_COMPARATOR | - |
| High-Dose Ziprasidone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Risperidone | DRUG | Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6 |
| Ziprasidone | DRUG | Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6 |
| Clozapine | DRUG | Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks |
Inclusion Criteria: * Hospitalized patients with schizophrenia * Miminum PANSS score of 60 when randomized Exclusion Criteria: * Planned, regular use of antipsyhotics within 1 week of randomization * Previous treatment with risperidone that resulted in intolerance or lack of response to risperido...