Phase 3
N=696
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02469155 ↗Enrolled (actual)
696
Serious AEs
0.1%
Results posted
Oct 2025
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ITI-007 (Drug); Risperidone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Aug 2016
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 |
— | — |
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.
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). 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.