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Study of a Novel Antipsychotic ITI-007 in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01499563
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Brief Summary:
The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ITI-007 Drug: Placebo Drug: Risperidone Phase 2

Detailed Description:

The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.

Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 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 : December 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: ITI-007 Low Dose Drug: ITI-007
Capsules containing ITI-007 for 28 days

Drug: Placebo
Capsules containing inactive placebo for 28 days

Experimental: ITI-007 High Dose Drug: ITI-007
Capsules containing ITI-007 for 28 days

Placebo Comparator: Placebo Drug: Placebo
Capsules containing inactive placebo for 28 days

Active Comparator: Risperidone Drug: Risperidone
Capsules containing risperidone for 28 days

Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Change from baseline to Day 28 ]

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Change from baseline to Day 8, 15, 22 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient's age is 18-55
  • Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
  • Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Exclusion Criteria:

  • Any female patient who is pregnant or breast-feeding
  • Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
  • Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
  • Any patient considered to be an imminent danger to themselves or others
  • Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
  • Any patient judged by the Investigator to be inappropriate for the study

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): NCT01499563

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United States, California
Long Beach, California, United States
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
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Study Director: Kimberly E Vanover, PhD Intra-Cellular Therapies
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: NCT01499563    
Other Study ID Numbers: ITI-007-005
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: September 2014
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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