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

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: NCT02469155
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE June 9, 2015
First Posted Date  ICMJE June 11, 2015
Last Update Posted Date November 14, 2017
Study Start Date  ICMJE June 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Positive and Negative Syndrome Scale Total Score [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Positive and Negative Syndrome Scale Subscales [ Time Frame: 6 weeks ]
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 Over 6 Weeks of Treatment
Official Title  ICMJE A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
Brief Summary 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.
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: Risperidone
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 20 mg ITI-007
    20 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
    Intervention: Drug: ITI-007
  • Experimental: 60 mg ITI-007
    60 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
    Intervention: Drug: ITI-007
  • Placebo Comparator: Placebo
    Placebo administered orally as visually-matched capsules once daily for 6 weeks
    Intervention: Drug: Placebo
  • Active Comparator: Risperidone
    Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
    Intervention: Drug: Risperidone
Publications * Not Provided

*   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 29, 2016)
696
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2015)
580
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (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 NCT02469155
Other Study ID Numbers  ICMJE ITI-007-302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Intra-Cellular Therapies, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Intra-Cellular Therapies, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc.
PRS Account Intra-Cellular Therapies, Inc.
Verification Date June 2016

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