ClinicalTrials.gov

History of Changes for Study: NCT02469155
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Latest version (submitted November 8, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 10, 2015 None (earliest Version on record)
2 June 23, 2015 Recruitment Status, Study Status and Contacts/Locations
3 June 29, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 March 9, 2017 Recruitment Status and Study Status
5 November 8, 2017 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02469155
Submitted Date:  June 10, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: ITI-007-302
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2015
Overall Status: Not yet recruiting
Study Start: June 2015
Primary Completion: May 2016 [Anticipated]
Study Completion: August 2016 [Anticipated]
First Submitted: June 9, 2015
First Submitted that
Met QC Criteria:
June 10, 2015
First Posted: June 11, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 10, 2015
Last Update Posted: June 11, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Intra-Cellular Therapies, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Schizophrenia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 580 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 20 mg ITI-007
20 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
Drug: ITI-007
Experimental: 60 mg ITI-007
60 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
Drug: ITI-007
Placebo Comparator: Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Drug: Placebo
Active Comparator: Risperidone
Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
Drug: Risperidone
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Positive and Negative Syndrome Scale Total Score
[ Time Frame: 6 weeks ]

Secondary Outcome Measures:
1. Positive and Negative Syndrome Scale Subscales
[ Time Frame: 6 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Kimberly Vanover, Ph.D.
Email: kvanover@intracellulartherapies.com
Study Officials: Kimberly Vanover, Ph.D.
Study Director
Intra-Cellular Therapies, Inc.
Locations: United States, California
Clinical Site
Long Beach, California, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services