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

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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.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 696 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- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
Study Start Date : June 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
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



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 ]


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

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): NCT02469155


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.
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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02469155    
Other Study ID Numbers: ITI-007-302
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: June 2016
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents