Back to resultsA Trial to Assess the Antipsychotic Efficacy of ITI-007
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITI-007
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 Type
Experimental
Experimental
Placebo Comparator
Arm Label
40 mg ITI-007
60 mg ITI-007
Placebo
Arm Description
40 mg ITI-007 administered orally as formulated capsules once daily for 28 days
60 mg ITI-007 administered orally as formulated capsules once daily for 28 days
Placebo administered orally as formulated capsules once daily for 28 days
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale Total Score
Secondary Outcome Measures
Positive and Negative Syndrome Scale Subscales
Full Information
NCT ID
NCT02282761
First Posted
October 31, 2014
Last Updated
March 9, 2017
Sponsor
Intra-Cellular Therapies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02282761
Brief Title
A Trial to Assess the Antipsychotic Efficacy of ITI-007
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40 mg ITI-007
Arm Type
Experimental
Arm Description
40 mg ITI-007 administered orally as formulated capsules once daily for 28 days
Arm Title
60 mg ITI-007
Arm Type
Experimental
Arm Description
60 mg ITI-007 administered orally as formulated capsules once daily for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally as formulated capsules once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
ITI-007
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale Total Score
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale Subscales
Time Frame
28 days
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
Citations:
PubMed Identifier
31913424
Citation
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 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379. Erratum In: JAMA Psychiatry. 2020 Feb 19;:
Results Reference
derived
Learn more about this trial
A Trial to Assess the Antipsychotic Efficacy of ITI-007
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