Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

NCT ID: NCT02288845

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ITI-007

ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects.

Group Type EXPERIMENTAL

ITI-007

Intervention Type DRUG

Interventions

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ITI-007

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with schizophrenia who are drug-free with regard to their antipsychotic medication
* In clinical remission and free from acute exacerbation of their psychosis
* In good health

Exclusion Criteria

* Clinically significant medical conditions considered inappropriate for trial participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Vanover, Ph.D.

Role: STUDY_DIRECTOR

Intra-Cellular Therapies, Inc. (ITI)

Dean F. Wong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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ITI-007-008

Identifier Type: -

Identifier Source: org_study_id

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