Study of Iloperidone Long-Acting Injection Versus Placebo for Treating Schizophrenia in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the effectiveness of iloperidone long-acting injection LAI compared to a placebo in preventing worsening symptoms in adults with schizophrenia. This is a Phase 3, double-blind, randomized withdrawal study sponsored by Vanda Pharmaceuticals, aiming to understand how well iloperidone LAI maintains symptom control in this population. The study begins with a 12-week stabilization phase where all participants receive open-label iloperidone, first as oral tablets for six weeks, followed by long-acting intramuscular injections for another six weeks. After stabilization, participants are randomly assigned to receive either iloperidone LAI or a matching placebo injection every few weeks for up to 52 weeks in a double-blind manner. Participants will be closely monitored throughout the study, including during the stabilization and randomized phases, to track the time until symptoms worsen. Researchers will assess changes in schizophrenia symptoms over the 52-week post-randomization period. Safety and adherence to the study drug will be observed, providing valuable information on the treatments ability to maintain symptom stability over time.

Randomized Withdrawal Study in Patients With Schizophrenia