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ITI-007 (Lumateperone Tosylate) for Schizophrenia

NCT03817528 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-11-04

Study results available
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Summary

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Conditions

Interventions

DRUG

ITI-007

ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    collaborator INDUSTRY

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Jeffrey A Lieberman, MD · New York State Psychiatric Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-09-23
Completion
2020-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03817528 on ClinicalTrials.gov