NCT03817528

ITI-007 (Lumateperone Tosylate) for Schizophrenia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients will be started on ITI-007 and current medication will be slowly discontinued within the first 7 days of starting ITI-007, with some flexibility allowed if clinically indicated. No patients will be left unmedicated because of this study. Patients will be seen weekly for the first 4 weeks, biweekly for the second month and then monthly for six months. Patients will be monitored by clinical and safety rating scales, and will be required to show improvement after 3 months to remain in this study. Patients not improving at this time will be assessed for the risks/benefits of continuing.

Conditions

• Schizophrenia

Interventions

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

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-09-23
• Completion: 2020-09-23
• First posted: 2019-01-25
• Last updated: 2021-11-04
• Results posted: 2021-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study