A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

Phase 3 Completed 696 enrolled Intra-Cellular Therapies, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

Timeline

Start: 2015-06
Primary completion: 2016-08
Completion: 2016-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Lumateperone 14 mg (ITI-007 20 mg Tosylate) vs Placebo; p = 0.972; Least Squares Mean Difference 0.1 (95% CI -3.39 to 3.51); NCT02469155 ↗

registry analysis (superiority test); Lumateperone 42 mg (ITI-007 60 mg Tosylate) vs Placebo; p = 0.789; Least Squares Mean Difference 0.5 (95% CI -2.92 to 3.84); NCT02469155 ↗

Publications

Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumateperone	Small molecule	14 mg	Oral
Subject	Lumateperone	Small molecule	42 mg	Oral
Comparator	Risperidone	Other / unclassified	—	Oral