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Study of a Novel Antipsychotic ITI-007 in Schizophrenia

NCT01499563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2025-10-03

Study results available
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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.

Conditions

Interventions

DRUG

ITI-007

Capsules containing ITI-007 for 28 days

DRUG

Placebo

Capsules containing inactive placebo for 28 days

DRUG

Risperidone

Capsules containing risperidone for 28 days

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Kimberly E Vanover, PhD · Intra-Cellular Therapies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-08-31
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499563 on ClinicalTrials.gov