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Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ITI-007

Placebo

Risperidone

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

ITI-007 Low Dose

ITI-007 High Dose

Placebo

Risperidone

Arm Description

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) total score

Secondary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) total score

Full Information

NCT ID

NCT01499563

First Posted

December 16, 2011

Last Updated

March 9, 2017

Sponsor

Intra-Cellular Therapies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01499563

Brief Title

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Official Title

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intra-Cellular Therapies, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

335 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ITI-007 Low Dose

Arm Type

Experimental

Arm Title

ITI-007 High Dose

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Risperidone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ITI-007

Intervention Description

Capsules containing ITI-007 for 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules containing inactive placebo for 28 days

Intervention Type

Drug

Intervention Name(s)

Risperidone

Intervention Description

Capsules containing risperidone for 28 days

Primary Outcome Measure Information:

Title

Positive and Negative Syndrome Scale (PANSS) total score

Time Frame

Change from baseline to Day 28

Secondary Outcome Measure Information:

Title

Positive and Negative Syndrome Scale (PANSS) total score

Time Frame

Change from baseline to Day 8, 15, 22

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberly E Vanover, PhD

Organizational Affiliation

Intra-Cellular Therapies

Official's Role

Study Director

Facility Information:

City

Long Beach

State/Province

California

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26444072

Citation

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.

Results Reference

derived

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Study of a Novel Antipsychotic ITI-007 in Schizophrenia

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