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

Arm | Intervention/treatment |
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Experimental: 40 mg ITI-007
40 mg ITI-007 administered orally as formulated capsules once daily for 28 days
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Drug: ITI-007 |
Experimental: 60 mg ITI-007
60 mg ITI-007 administered orally as formulated capsules once daily for 28 days
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Drug: ITI-007 |
Placebo Comparator: Placebo
Placebo administered orally as formulated capsules once daily for 28 days
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Drug: Placebo |
- Positive and Negative Syndrome Scale Total Score [ Time Frame: 28 days ]
- Positive and Negative Syndrome Scale Subscales [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, California | |
Clinical Site | |
Long Beach, California, United States |
Study Director: | Kimberly Vanover, Ph.D. | Intra-Cellular Therapies, Inc. |
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 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |