Back to resultsA Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITI-007
Risperidone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
20 mg ITI-007
60 mg ITI-007
Placebo
Risperidone
Arm Description
20 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
60 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale Total Score
Secondary Outcome Measures
Positive and Negative Syndrome Scale Subscales
Full Information
NCT ID
NCT02469155
First Posted
June 9, 2015
Last Updated
November 8, 2017
Sponsor
Intra-Cellular Therapies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02469155
Brief Title
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
696 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 mg ITI-007
Arm Type
Experimental
Arm Description
20 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
Arm Title
60 mg ITI-007
Arm Type
Experimental
Arm Description
60 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Arm Title
Risperidone
Arm Type
Active Comparator
Arm Description
Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
ITI-007
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale Total Score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale Subscales
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Vanover, Ph.D.
Organizational Affiliation
Intra-Cellular Therapies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Long Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
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