| Completed | A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects Healthy Volunteers | Phase 1 | 2025-01-28 |
| Recruiting | Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder ( Irritability Associated With Autism Spectrum Disorder | Phase 3 | 2024-12-06 |
| Recruiting | Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder i Irritability Associated With Autism Spectrum Disorder | Phase 3 | 2024-11-22 |
| Recruiting | Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder Generalized Anxiety Disorder | Phase 2 | 2024-11-21 |
| Recruiting | A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer' Agitation Associated With Alzheimer's Dementia | Phase 2 | 2024-10-22 |
| Completed | Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients Wit Schizophrenia or Schizoaffective | Phase 1 | 2024-08-23 |
| Recruiting | A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer' Psychosis Associated With Alzheimer's Disease | Phase 2 | 2024-08-15 |
| Recruiting | Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Generalized Anxiety Disorder | Phase 2 | 2024-08-05 |
| Recruiting | Study of Lumateperone in the Treatment of Patients With Bipolar Mania Bipolar Disorder, Manic | Phase 3 | 2024-07-17 |
| Recruiting | Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania Bipolar Disorder, Manic | Phase 3 | 2024-06-19 |
| Recruiting | Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients Bipolar Depression | Phase 3 | 2024-05-13 |
| Recruiting | Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder Autism Spectrum Disorder | Phase 1 | 2024-05-10 |
| Recruiting | PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects Healthy Volunteers | Phase 1 | 2024-04-11 |
| Recruiting | Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Au Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder | Phase 3 | 2024-01-25 |
| Recruiting | Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Major Depressive Disorder | Phase 3 | 2023-05-02 |
| Recruiting | Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Dise Parkinson Disease | Phase 2 | 2023-03-13 |
| Completed | Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Healthy Volunteers | Phase 1 | 2023-01-18 |
| Completed | A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects Healthy Volunteers | Phase 1 | 2022-07-26 |
| Completed | An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive D Major Depressive Disorder | Phase 3 | 2021-10-08 |
| Completed | Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Dis Major Depressive Disorder | Phase 3 | 2021-09-30 |
| Completed | Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disord Major Depressive Disorder | Phase 3 | 2021-07-30 |
| Completed | Lumateperone for the Prevention of Relapse in Patients With Schizophrenia Schizophrenia | Phase 3 | 2021-07-08 |
| Completed | Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoa Schizophrenia, Pediatric | Phase 1 | 2021-03-12 |
| Completed | Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophren Schizophrenia | Phase 1 | 2020-12-30 |
| Completed | Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy V Healthy Volunteers | Phase 1 | 2020-12-23 |
| Completed | Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Bipolar Depression, Major Depressive Disorder | Phase 3 | 2020-02-27 |
| Completed | Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement Healthy Volunteers | Phase 1 | 2018-07-10 |
| Completed | Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Heart Failure, Systolic | Phase 1 / Phase 2 | 2018-07-10 |
| Completed | Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally Bipolar Depression | Phase 3 | 2017-11-27 |
| Completed | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease Parkinson Disease | Phase 1 / Phase 2 | 2017-09-28 |
| Terminated | ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease Agitation in Dementia, Including Alzheimer's Disease | Phase 3 | 2016-08-29 |
| Completed | Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipola Bipolar Depression | Phase 3 | 2016-03-07 |
| Completed | Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression Bipolar Depression | Phase 3 | 2015-12-15 |
| Completed | A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment Schizophrenia | Phase 3 | 2015-06-01 |
| Completed | A Trial to Assess the Antipsychotic Efficacy of ITI-007 Schizophrenia | Phase 3 | 2014-11-01 |
| Completed | Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia Schizophrenia | Phase 2 | 2014-10-01 |
| Completed | Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia Alzheimer's Disease | Phase 1 / Phase 2 | 2014-02-01 |
| Completed | Study of a Novel Antipsychotic ITI-007 in Schizophrenia Schizophrenia | Phase 2 | 2011-12-01 |