A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2018

At a glance

  • Drugs Lumateperone (Primary) ; Risperidone
  • Indications Schizophrenia
  • Focus Therapeutic Use
  • Sponsors Intra-Cellular Therapies
  • Most Recent Events

    • 06 Jun 2018 According to an Intra-Cellular Therapies media release, the company has initiated rolling submission of the New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for lumateperone for the treatment of schizophrenia. The Company plans to complete this NDA submission in mid-2018.
    • 04 May 2018 According to an Intra-Cellular Therapies media release, results from this study will be presented at the 2018 American Psychiatric Association (APA) Annual Meeting.
    • 13 Mar 2018 According to an Intra-Cellular Therapies media release, company had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) and plans to complete its NDA submission by mid-2018.
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