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NCT02469155 Clinical Trial

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

Schizophrenia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02469155
Other study ID # ITI-007-302
Secondary ID
Status Completed
Phase Phase 3
First received June 9, 2015
Last updated November 8, 2017
Start date June 2015
Est. completion date August 2016

Study information
Verified date June 2016
Source Intra-Cellular Therapies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 696
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ITI-007

• Risperidone

• Placebo

Locations
Country Name City State
United States Clinical Site Long Beach California

Sponsors (1)
Lead Sponsor Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive and Negative Syndrome Scale Total Score 6 weeks
Secondary Positive and Negative Syndrome Scale Subscales 6 weeks
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