Study of a Novel Antipsychotic ITI-007 in Schizophrenia

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Long Beach, California, United States

Sponsors and Collaborators

Intra-Cellular Therapies, Inc.

Investigators

• Study Director: Kimberly E Vanover, PhD; Intra-Cellular Therapies

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lieberman JA, Davis RE, Correll CU, Goff DC, Kane JM, Tamminga CA, Mates S, Vanover KE. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31.

• Responsible Party: Intra-Cellular Therapies, Inc.
• ClinicalTrials.gov Identifier: NCT01499563
• Other Study ID Numbers: ITI-007-005
• First Posted: December 26, 2011
• Last Update Posted: March 10, 2017
• Last Verified: September 2014

Additional relevant MeSH terms:

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