ITI-007

DRUG7 trials

Sponsors

Intra-Cellular Therapies, Inc., New York State Psychiatric Institute

Conditions

Agitation in Dementia, Including Alzheimer's DiseaseAlzheimer's DiseaseSchizophrenia

Phase 1

Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

CompletedNCT02078310

Intra-Cellular Therapies, Inc.Alzheimer's Disease

Start: 2014-02-28End: 2014-11-30Updated: 2017-11-17

Phase 2

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

CompletedNCT01499563

Intra-Cellular Therapies, Inc.Schizophrenia

Start: 2011-12-31End: 2013-11-30Updated: 2025-10-03

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

CompletedNCT02288845

Intra-Cellular Therapies, Inc.Schizophrenia

Start: 2014-10-31End: 2015-09-30Updated: 2017-03-10

ITI-007 (Lumateperone Tosylate) for Schizophrenia

TerminatedNCT03817528

New York State Psychiatric InstituteSchizophrenia

Start: 2019-03-01End: 2020-09-23Updated: 2021-11-04

Phase 3

A Trial to Assess the Antipsychotic Efficacy of ITI-007

CompletedNCT02282761

Intra-Cellular Therapies, Inc.Schizophrenia

Start: 2014-11-30End: 2015-09-30Updated: 2025-10-02

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

CompletedNCT02469155

Intra-Cellular Therapies, Inc.Schizophrenia

Start: 2015-06-30End: 2016-08-31Updated: 2025-10-02

ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

TerminatedNCT02817906

Intra-Cellular Therapies, Inc.Agitation in Dementia, Including Alzheimer's Disease

Start: 2016-08-29End: 2019-01-30Updated: 2021-06-29

Related Papers

Lumateperone in Pooled Late-Phase Schizophrenia Trials: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed

CNS Spectrums2023-04-01

Lumateperone for the Treatment of Schizophrenia

The Journal of Clinical Psychiatry2023-03-027 citations

S221. THE EFFICACY OF LUMATEPERONE 42 MG IN THE TREATMENT OF SCHIZOPHRENIA SYMPTOMS ASSOCIATED WITH SOCIAL FUNCTIONING: POST HOC ANALYSIS OF AN ACUTE PLACEBO- AND ACTIVE-CONTROLLED TRIAL

Schizophrenia Bulletin2020-04-011 citations

Efficacy and Safety of Lumateperone for Treatment of Schizophrenia

JAMA Psychiatry2020-01-08276 citations