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A Trial to Assess the Antipsychotic Efficacy of ITI-007

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ITI-007 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Study Start Date : November 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 40 mg ITI-007
40 mg ITI-007 administered orally as formulated capsules once daily for 28 days
 Drug: ITI-007
Experimental: 60 mg ITI-007
60 mg ITI-007 administered orally as formulated capsules once daily for 28 days
 Drug: ITI-007
Placebo Comparator: Placebo
Placebo administered orally as formulated capsules once daily for 28 days
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale Total Score [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale Subscales [ Time Frame: 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282761


Locations
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United States, California
Clinical Site
Long Beach, California, United States
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
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Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02282761    
Other Study ID Numbers: ITI-007-301
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: November 2015
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders