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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06961968 | Randomized Withdrawal Study in Patients With Schizophrenia | PHASE3 | RECRUITING | 400 | — | — | May 14, 2025 | Nov 1, 2027 | Jan 12, 2026 | 22 | United States |
| NCT01291511 | Relapse Prevention Study in Patients With Schizophrenia | PHASE3 | COMPLETED | 635 | — | — | Feb 1, 2011 | Mar 1, 2015 | Jul 17, 2023 | 63 | United States, India +1 |
| NCT00254202 | Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia | PHASE3 | COMPLETED | 593 | — | — | Nov 18, 2005 | Mar 21, 2007 | Dec 13, 2024 | 42 | United States, India |
| NCT04712734 | A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia | PHASE1 | COMPLETED | 42 | — | — | Jan 13, 2021 | Aug 30, 2022 | Jun 29, 2023 | 3 | United States |
As measured by the time to first exacerbation of psychiatric symptoms
Relapse or impending relapse was defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of the PANSS total score of greater than or equal to 30% from randomization, PANSS total score confirmed at a second visit conducted within 1-7 days; clinically significant emergent or worsening suicidal, homicidal, or aggressive behavior; a CGI-Improvement (CGI-I) score of 6 (much worse) or 7 (very much worse) after randomization; a dose increase in study medication or a need for additional open-label antipsychotic treatment.
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
As measured by plasma concentrations.
As measured by spontaneous reporting of adverse events (AEs).
| Arm | Type | Description |
|---|---|---|
| iloperidone | EXPERIMENTAL | During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks. |
| placebo | PLACEBO_COMPARATOR | During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks. |
| Ziprasidone | ACTIVE_COMPARATOR | Oral ziprasidone |
| Name | Type | Description |
|---|---|---|
| iloperidone | DRUG | iloperidone LAI |
| placebo | DRUG | matching placebo |
| Ziprasidone | DRUG | - |
Inclusion Criteria: * Males or females 18 to 65 years of age (inclusive) * Diagnosed with schizophrenia per DSM-5 criteria * In need of ongoing psychiatric treatment Exclusion Criteria: * DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment wi...