Phase 3
Completed N=696
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Source: ClinicalTrials.gov NCT02469155 ↗Enrolled (actual)
696
Serious AEs
0.1%
Results posted
Oct 2025
Primary outcomePrimary: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score — -15.0; -14.6; -15.1; -20.5 units on a scale — p=0.972
◆ Published Evidence
Emerging
7citations · ~2 / year
Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.
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.
Linked Publications
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Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-15.0; -14.6; -15.1; -20.5 | 0.972 |
| SECONDARY Change From Baseline to Week 6 in Clinical Global Impressions-Severity of Illness Scale |
— | — |
Eligibility Criteria
Inclusion Criteria
- male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
- experiencing an acute exacerbation of psychosis
Exclusion Criteria
- any subject unable to provide informed consent
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
Data sourced from ClinicalTrials.gov (NCT02469155) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.