Phase 3 N=449 Randomized Quadruple-blind Treatment

A Trial to Assess the Antipsychotic Efficacy of ITI-007

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02282761 ↗

Enrolled (actual)

449

Serious AEs

0.4%

Results posted

Oct 2025

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ITI-007 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Intra-Cellular Therapies, Inc.
Primary completion: Jul 2015

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02282761). 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.