CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 335 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/NCT01499563
NCT01499563Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Intra-Cellular Therapies, Inc.·interventional·Posted Dec 26, 2011·Updated Oct 3, 2025

In Brief

A Phase 2 clinical trial evaluating ITI-007, Placebo, and 1 other intervention for Schizophrenia. Completed, enrolled 335 participants across 8 sites.

Detailed Summary

The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 26, 2011
Enrollment StartDec 1, 2011
Primary CompletionAug 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.5 years ago

Interventions

ITI-007drug

Capsules containing ITI-007 for 28 days

Placebodrug

Capsules containing inactive placebo for 28 days

Risperidonedrug

Capsules containing risperidone for 28 days