drugset

drugset / Trial / NCT01291511

Relapse Prevention Study in Patients With Schizophrenia

NCT01291511 ↗

Phase 3 Completed 635 enrolled Vanda Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia

Timeline

Start: 2011-02
Primary completion: 2014-03
Completion: 2015-03

Outcome

Met primary endpoint

registry analysis (superiority test); Iloperidone vs Placebo; p <0.0001; Cox Proportional Hazard 5.2 (95% CI 3.2 to 8.4); Log Rank NCT01291511 ↗

paper iloperidone (n = 97) was more effective than placebo (n = 96) in preventing relapse events PMID 27379654 ↗

Publications

Results Weiden PJ, Manning R, Wolfgang CD, Ryan JM, Mancione L, Han G, Ahmed S, Mayo MG. A Randomized Trial of Iloperidone for Prevention of Relapse in Schizophrenia: The REPRIEVE Study. CNS Drugs. 2016 Aug;30(8):735-47. doi: 10.1007/s40263-016-0345-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iloperidone	Small molecule	12 mg	Oral

Indications