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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02288845

Enrollment

Registered

2014-11-11

Start date

2014-10-31

Completion date

2015-09-30

Last updated

2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

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.

Interventions

DRUGITI-007

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Brain Receptor Occupancy as Measured by Positron Emission Tomography	Up to 14 days

Secondary

Measure	Time frame
Safety and Tolerability as Measured by Number of Participants with Adverse Events	Up to 14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026