A Phase 3 interventional study of iloperidone and placebo in Schizophrenia, sponsored by Vanda Pharmaceuticals. Recruiting at 22 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's planned enrollment of 400 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: iloperidone
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.
Drug: placebo
iloperidone LAI
matching placebo
Time to exacerbation of symptoms
As measured by the time to first exacerbation of psychiatric symptoms
Time frame: Up to 52 weeks post-randomization
Plan to share: No
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Vanda Pharmaceuticals