CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 696 enrolled
Drug / intervention
ITI-007 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02469155
NCT02469155Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia

Intra-Cellular Therapies, Inc.·interventional·Posted Jun 11, 2015·Updated Oct 2, 2025

In Brief

A Phase 3 clinical trial evaluating ITI-007, Risperidone, and 1 other intervention for Schizophrenia. Completed, enrolled 696 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 11, 2015
Enrollment StartJun 1, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago

Interventions

ITI-007drug

Risperidonedrug

Placebodrug