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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ITI-007

• Registration Number: NCT02288845
• Lead Sponsor: Intra-Cellular Therapies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2015-11
• Disposition First Submitted: 2017-03-09
• Disposition First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Disposition First Posted: 2017-03-10
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

• Clinically significant medical conditions considered inappropriate for trial participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Brain Receptor Occupancy as Measured by Positron Emission Tomography	Up to 14 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Medical Institutions; 🇺🇸 Baltimore, Maryland, United States