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A Trial to Assess the Antipsychotic Efficacy of ITI-007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02282761
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE October 31, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
Positive and Negative Syndrome Scale Total Score [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02282761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
Positive and Negative Syndrome Scale Subscales [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Assess the Antipsychotic Efficacy of ITI-007
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Brief Summary The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: ITI-007
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 40 mg ITI-007
    40 mg ITI-007 administered orally as formulated capsules once daily for 28 days
    Intervention: Drug: ITI-007
  • Experimental: 60 mg ITI-007
    60 mg ITI-007 administered orally as formulated capsules once daily for 28 days
    Intervention: Drug: ITI-007
  • Placebo Comparator: Placebo
    Placebo administered orally as formulated capsules once daily for 28 days
    Intervention: Drug: Placebo
Publications * Correll CU, Davis RE, Weingart M, Saillard J, O'Gorman C, Kane JM, Lieberman JA, Tamminga CA, Mates S, Vanover KE. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jan 8. doi: 10.1001/jamapsychiatry.2019.4379. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2015)
450
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
440
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282761
Other Study ID Numbers  ICMJE ITI-007-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intra-Cellular Therapies, Inc.
Study Sponsor  ICMJE Intra-Cellular Therapies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc.
PRS Account Intra-Cellular Therapies, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP