drugset / Trial / NCT01499563
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.
Timeline
- Start
- 2011-12
- Primary completion
- 2013-08
- Completion
- 2013-11
Outcome
Met primary endpoint
registry p = 0.017; Least Squares Mean Difference -5.8 (95% CI -11.1 to -0.4) NCT01499563 ↗
paper demonstrated antipsychotic efficacy superiority over placebo on the primary end point. PMID 26444072 ↗
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.
- Lieberman JA, Davis RE, Correll CU, Goff DC, Kane JM, Tamminga CA, Mates S, Vanover KE. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumateperone | Small molecule | 42 mg | — |
| Subject | Lumateperone | Small molecule | 84 mg | — |
| Comparator | Risperidone | Other / unclassified | 4 mg | — |