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Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31.

ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial.

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Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital, New York, New York.
Intra-Cellular Therapies, Inc., New York, New York; 3-D Pharmaceutical Consultants, San Diego, California.
Department of Psychiatry, Hofstra North Shore Long Island Jewish School of Medicine, Hempstead; Zucker Hillside Hospital Glen Oaks, New York.
Department of Psychiatry, New York University Langone Medical Center, New York; Nathan Kline Institute for Psychiatric Research, Orangeburg, New York.
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.
Intra-Cellular Therapies, Inc., New York, New York.
Intra-Cellular Therapies, Inc., New York, New York. Electronic address:



An urgent need exists for new treatments of schizophrenia that are effective against a broad range of symptoms and free of limiting safety issues. ITI-007 is a new molecular entity with a pharmacologic profile that combines dose-related monoamine modulation with phosphorylation of intracellular signaling proteins.


A phase II randomized, double-blind, placebo-controlled, and active-controlled trial was conducted at eight sites in the United States with randomization of 335 acutely psychotic adults with schizophrenia. ITI-007 (60 mg and 120 mg), placebo, and risperidone, included for assay sensitivity, were evaluated as monotherapy for 4 weeks. The primary outcome measure was the Positive and Negative Syndrome Scale total score, with secondary analyses conducted on symptom subscales.


ITI-007 60 mg (p = .017, effect size = .4) and risperidone (p = .013, effect size = .4) demonstrated antipsychotic efficacy superiority over placebo on the primary end point. The results of secondary analyses reflected improvements in negative and depressive symptoms by ITI-007 60 mg. ITI-007 120 mg did not separate from placebo. However, both doses of ITI-007 were well tolerated in this patient population, as evidenced by low discontinuation and adverse event rates, and were associated with a benign metabolic profile as evidenced by significantly lower levels of prolactin, fasting glucose, total cholesterol, and triglycerides than risperidone.


The mechanistically novel investigational drug ITI-007 was effective for the treatment of schizophrenia and comparable with placebo on safety measures in this trial. Secondary analyses indicated that ITI-007 improved negative and depression symptoms and might have expanded therapeutic efficacy in comparison with current antipsychotic drugs.



Antipsychotic; Comorbid depression; Negative symptoms; Positive symptoms; Prosocial factor; Safety

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