Phase 3
Completed N=449
A Trial to Assess the Antipsychotic Efficacy of ITI-007
Source: ClinicalTrials.gov NCT02282761 ↗Enrolled (actual)
449
Serious AEs
0.4%
Results posted
Oct 2025
Primary outcomePrimary: Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score — -12.9; -14.5; -10.3 units on a scale — p=0.182
◆ Published Evidence
Highly cited
279citations · ~47 / year
Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial.
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.
Linked Publications (2)
-
Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial.
-
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 Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-12.9; -14.5; -10.3 | 0.182 |
| SECONDARY Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale |
-0.8; -0.8; -0.5 | 0.045 sig |
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 (NCT02282761) 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.