drugset / Trial / NCT02282761
A Trial to Assess the Antipsychotic Efficacy of ITI-007
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-07
- Completion
- 2015-09
Outcome
Mixed primary results
paper 42 mg of lumateperone met the primary and key secondary efficacy objectives PMID 31913424 ↗
registry Lumateperone 42 mg (ITI-007 60 mg Tosylate) vs Placebo; p = 0.045; Least Squares Mean Difference -4.2 (95% CI -7.75 to -0.60) NCT02282761 ↗
registry Lumateperone 28 mg (ITI-007 40 mg Tosylate) vs Placebo; p = 0.182; Least Squares Mean Difference -2.6 (95% CI -6.17 to 1.05) NCT02282761 ↗
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.
- Correll CU, Davis RE, Weingart M, Saillard J, O'Gorman C, Kane JM, Lieberman JA, Tamminga CA, Mates S, Vanover KE. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumateperone | Small molecule | 28 mg | Oral |
| Subject | Lumateperone | Small molecule | 42 mg | Oral |