Small molecules for neurology
Total Trials
42
As Lead Sponsor
38
As Collaborator
4
Total Enrollment
10,746
NCT01499563
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
Phase: Phase 2
Role: Lead Sponsor
Start: Dec 31, 2011
Completion: Nov 30, 2013
NCT01900522
Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia
Phase: Phase 1
Role: Collaborator
Start: Jul 31, 2013
Completion: Dec 31, 2014
NCT02078310
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
Phase: Phase 1/2
Start: Feb 28, 2014
Completion: Nov 30, 2014
NCT02288845
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
Start: Oct 31, 2014
Completion: Sep 30, 2015
NCT02282761
A Trial to Assess the Antipsychotic Efficacy of ITI-007
Phase: Phase 3
Start: Nov 30, 2014
NCT02469155
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Start: Jun 30, 2015
Completion: Aug 31, 2016
NCT02600494
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Start: Dec 15, 2015
Completion: Jul 24, 2019
NCT02600507
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Start: Mar 7, 2016
Completion: Jul 2, 2020
NCT02817906
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Start: Aug 29, 2016
Completion: Jan 30, 2019
NCT03257046
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Start: Sep 28, 2017
Completion: Sep 28, 2018
NCT03249376
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Start: Nov 27, 2017
Completion: Mar 1, 2019
NCT03387215
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Start: Jul 10, 2018
Completion: Mar 16, 2020
NCT03489772
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
Completion: Aug 5, 2019
NCT03817528
ITI-007 (Lumateperone Tosylate) for Schizophrenia
Start: Mar 1, 2019
Completion: Sep 23, 2020
NCT04285515
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Start: Feb 27, 2020
Completion: Nov 30, 2022
NCT04934124
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Start: Dec 23, 2020
Completion: Aug 23, 2021
NCT04709224
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
Start: Dec 30, 2020
Completion: May 23, 2022
NCT04779177
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Start: Mar 12, 2021
Completion: Jul 30, 2022
NCT04959032
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Start: Jul 8, 2021
Completion: Aug 7, 2024
NCT04985942
Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Start: Jul 30, 2021
Completion: Feb 27, 2024
NCT05061706
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Start: Sep 30, 2021
Completion: Apr 12, 2024
NCT05061719
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Start: Oct 8, 2021
Completion: Oct 23, 2024
NCT05470101
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
Start: Jul 26, 2022
Completion: May 3, 2023
NCT05732194
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Start: Jan 18, 2023
Completion: Sep 1, 2023
NCT05766813
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
Start: Mar 13, 2023
Completion: Oct 31, 2025
NCT05850689
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Start: May 2, 2023
Completion: Oct 31, 2026
NCT05356013
Caplyta in Borderline Personality Disorder
Start: May 10, 2023
Completion: Dec 31, 2025
NCT06229210
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Start: Jan 25, 2024
Completion: Dec 31, 2027
NCT06174116
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Phase: Phase 4
Start: Apr 2, 2024
Completion: Nov 30, 2026
NCT06299410
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
Start: Apr 11, 2024
Completion: Sep 30, 2025
NCT06557902
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Start: May 10, 2024
Completion: Jul 31, 2026
NCT06372964
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Start: May 13, 2024
Completion: May 31, 2027
NCT06462586
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Start: Jun 19, 2024
Completion: Apr 30, 2026
NCT06462612
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
Start: Jul 17, 2024
Completion: Jun 30, 2026
NCT06480383
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
Start: Aug 5, 2024
Completion: Jun 30, 2027
NCT06540833
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Start: Aug 15, 2024
Completion: Oct 31, 2027
NCT06627413
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Start: Aug 23, 2024
Completion: Mar 31, 2026
NCT06651567
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Start: Oct 22, 2024
Completion: Nov 30, 2027
NCT06701903
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
Start: Nov 21, 2024
NCT06690398
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Start: Nov 22, 2024
Completion: Apr 30, 2027
NCT06706674
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Start: Dec 6, 2024
NCT06786286
A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
Start: Jan 28, 2025
Completion: Mar 26, 2025
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