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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02469155

Run by

Intra-Cellular Therapies, Inc.

People needed

696

Starts

2015-06-01

Expected to finish

2016-08-01

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
• experiencing an acute exacerbation of psychosis

You may not qualify if…

• 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

Where it is running

• Clinical Site — Little Rock, Arkansas, United States
• Clinical Site — Springdale, Arkansas, United States
• Clinical Site — Culver City, California, United States
• Clinical Site — Lemon Grove, California, United States
• Clinical Site — Long Beach, California, United States
• Clinical Site — San Diego, California, United States
• Clinical Site — North Miami, Florida, United States
• Clinical Site — Berlin, New Jersey, United States
• Clinical Site — Marlton, New Jersey, United States
• Clinical Site — Austin, Texas, United States
• Clinical Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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