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

Intra-Cellular Therapies

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: ITI-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT02288845

ITI-007-008

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

ITI-007

Experimental group

Description:

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

Treatment:

Drug: ITI-007