NCT02288845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 10, 2017

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

October 31, 2014

Last Update Submit

March 9, 2017

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Brain Receptor Occupancy as Measured by Positron Emission Tomography

    Up to 14 days

Secondary Outcomes (1)

  • Safety and Tolerability as Measured by Number of Participants with Adverse Events

    Up to 14 days

Study Arms (1)

ITI-007

EXPERIMENTAL

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

Drug: ITI-007

Interventions

ITI-007DRUG
ITI-007

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Clinically significant medical conditions considered inappropriate for trial participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Kimberly Vanover, Ph.D.

    Intra-Cellular Therapies, Inc. (ITI)

    STUDY DIRECTOR

  • Dean F. Wong, M.D., Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 11, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

March 10, 2017

Record last verified: 2015-11

Locations

US(1)