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Intra-Cellular Therapies Announces the Successful Completion of a Phase Ib/II Study of ITI-007 in Patients with Schizophrenia
Date:7/29/2010

significant efficacy in this patient population.

In the current study, total PANSS scores improved in this patient population after ITI-007 administration.  Furthermore, patients who had been randomized to ITI-007 also exhibited improvements in symptoms of depression and sleep.  Although the present study was not powered to demonstrate statistically significant differences in these outcomes, the clinical signals elicited by ITI-007 are encouraging and will be evaluated more fully in future efficacy studies.

A previous study in healthy volunteers demonstrated rapid engagement of target brain receptors with ITI-007 and long-lasting brain residency time using positron emission tomography (PET).  ITI-007 also showed dose-related increases in occupancy of target brain receptors and transporters that are important for antipsychotic and antidepressant efficacy and for enhancing sleep maintenance, such as dopamine D2 receptors, serotonin 5-HT2A receptors, and serotonin transporters.

ABOUT SCHIZOPHRENIA

Schizophrenia is a major neuropsychiatric disorder that affects over one percent of the world population with an illness that begins in late adolescence and lasts a lifetime. Its best known symptoms are "positive symptoms", which include hallucinations and delusions; but other mental functions are also affected, including social and motivational skills ("negative symptoms") and cognitive behaviors, like inattention and poor memory.  Current antipsychotics are effective primarily on reducing positive symptoms but leave negative and cognitive symptoms untouched. Not only are current drugs incompletely effective, but they also have limiting side effects, including troublesome actions on motor function, weight gain, and metabolic symptoms (diabetes and hyperlipidemia), along with sedation, constipation, dizziness, and loss o
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SOURCE Intra-Cellular Therapies, Inc.
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1. Intra-Cellular Therapies Announces the Results of a Phase I PET Study for ITI-007 for the Treatment of Schizophrenia and Other Psychiatric Disorders
2. Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
3. Intra-Cellular Therapies Announces the Discovery of Potent Antidepressant Activity in ITI-007
4. Intra-Cellular Therapies Announces the Discovery of Potent Antidepressant Activity in ITI-007/ITI-722
5. Intra-Cellular Therapies Presents Data on Its Schizophrenia and Cognition in Schizophrenia Programs at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
6. Intra-Cellular Therapies Initiates Phase 2 Clinical Trial for Sleep Maintenance Insomnia
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