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NCT02288845 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02288845
Other study ID # ITI-007-008
Secondary ID
Status Completed
Phase Phase 2
First received October 31, 2014
Last updated March 9, 2017
Start date October 2014
Est. completion date September 2015

Study information
Verified date November 2015
Source Intra-Cellular Therapies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date September 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ITI-007

Locations
Country Name City State
United States Johns Hopkins Medical Institutions Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brain Receptor Occupancy as Measured by Positron Emission Tomography Up to 14 days
Secondary Safety and Tolerability as Measured by Number of Participants with Adverse Events Up to 14 days
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