Expired Study
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Baltimore, Maryland 21287


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

ITI-007-008


NCT ID:

NCT02288845


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Intra-Cellular Therapies, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kimberly Vanover, Ph.D.
Study Director
Intra-Cellular Therapies, Inc. (ITI)

Study Dates

Start Date:October 2014
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:July 2015
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:March 9, 2017
First Received Date:October 31, 2014

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:ITI-007
Arm Name:ITI-007

Study Arms

Study Arm Type:Experimental
Arm Name:ITI-007
Description:ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Intra-Cellular Therapies, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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