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OpenTrials
Completed

NCT Number: NCT02288845

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITI-007

Drug

Primary outcomes

  1. Brain Receptor Occupancy as Measured by Positron Emission Tomography

    Time frame: Up to 14 days

Secondary outcomes

  1. Safety and Tolerability as Measured by Number of Participants with Adverse Events

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Intra-Cellular Therapies, Inc.

Industry

Registry information

Official study title

An Open-Label Positron Emission Tomography (PET) Study to Demonstrate Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of ITI-007 in Stable Schizophrenia Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2014
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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