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ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:42 AM EDT

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Showing 1–24 of 36 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Lumateperone Clear all
Completed Phase 1 Interventional

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia

NCT04709224
View directory record Official record
Conditions
Schizophrenia
Interventions
Lumateperone Long-Acting Injectable
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
2
States / cities
Long Beach, California • Marlton, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 5, 2022 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 2 Interventional

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

NCT07734103
View directory record Official record
Conditions
Stuttering, Adult
Interventions
Lumateperone (ITI-007), Placebo Tablet or Capsule
Drug
Lead sponsor
CSTrials Inc.
Network
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Costa Mesa, California
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

NCT03249376
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lumateperone, Placebo
Drug · Other
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
381 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
14
States / cities
Birmingham, Alabama • Sherman Oaks, California • Miami, Florida + 11 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2022 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 3 Interventional

Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT05850689
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
470 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
25
States / cities
Huntsville, Alabama • Pico Rivera, California • Farmington, Connecticut + 21 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Withdrawn Phase 4 Interventional Accepts healthy volunteers

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

NCT05890768
View directory record Official record
Conditions
Psychosis
Interventions
Lumateperone, Risperidone
Drug
Lead sponsor
University of New Mexico
Other
Eligibility
18 Years to 40 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2024
U.S. locations
1
States / cities
Albuquerque, New Mexico
Source: ClinicalTrials.gov public record
Updated Mar 5, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Not yet recruiting Phase 4 Interventional

Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse

NCT07369115
View directory record Official record
Conditions
Major Depressive Diorder, Early Life Trauma
Interventions
Lumateperone 42 mg, Placebo
Drug · Other
Lead sponsor
University of Texas at Austin
Other
Eligibility
21 Years to 70 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Jan 27, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 1 Interventional Results available

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

NCT04779177
View directory record Official record
Conditions
Schizophrenia, Pediatric
Interventions
Lumateperone 42 mg, Lumateperone 28 mg
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
3
States / cities
Hollywood, Florida • Atlanta, Georgia • Decatur, Georgia
Source: ClinicalTrials.gov public record
Updated Nov 12, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

NCT04285515
View directory record Official record
Conditions
Bipolar Depression, Major Depressive Disorder
Interventions
Lumateperone, Placebos
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
488 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
13
States / cities
Garden Grove, California • Oceanside, California • Sherman Oaks, California + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 19, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 3 Interventional

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

NCT06690398
View directory record Official record
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
Lumateperone high dose, Lumateperone low dose, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
5 Years to 17 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
35
States / cities
Dothan, Alabama • Phoenix, Arizona • Anaheim, California + 28 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT05061706
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
480 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
17
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Newport Beach, California + 14 more
Source: ClinicalTrials.gov public record
Updated May 9, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

NCT02600494
View directory record Official record
Conditions
Bipolar Depression
Interventions
ITI-007 (Lumateperone), Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
554 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
55
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Cerritos, California + 52 more
Source: ClinicalTrials.gov public record
Updated Nov 3, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 4 Interventional

The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression

NCT07699445
View directory record Official record
Conditions
Bipolar Depression Depressed Phase, Obesity & Overweight
Interventions
Lumateperone 42 mg
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 11, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 3 Interventional

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

NCT06229210
View directory record Official record
Conditions
Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
Interventions
Lumateperone
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
5 Years to 17 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2032
U.S. locations
59
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Anaheim, California + 43 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

NCT02600507
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lumateperone (ITI-007), Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
529 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
42
States / cities
Rogers, Arkansas • Cerritos, California • Costa Mesa, California + 39 more
Source: ClinicalTrials.gov public record
Updated May 17, 2023 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 1 Interventional

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

NCT06557902
View directory record Official record
Conditions
Autism Spectrum Disorder
Interventions
Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule, Lumateperone 5 mg ODT, Lumateperone 10.5 mg ODT, Lumateperone 15.5 mg ODT, Lumateperone 21 mg ODT
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
5 Years to 12 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
7
States / cities
Orlando, Florida • Atlanta, Georgia • Savannah, Georgia + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 24, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT04985942
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
485 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
15
States / cities
Phoenix, Arizona • Glendale, California • Oceanside, California + 12 more
Source: ClinicalTrials.gov public record
Updated May 2, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 3 Interventional

Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

NCT06482554
View directory record Official record
Conditions
Apathy, Schizophrenia, Schizophrenia; Psychosis
Interventions
Lumateperone 42 mg, Risperidone 2 mg
Drug
Lead sponsor
Louisiana State University Health Sciences Center Shreveport
Other
Eligibility
18 Years to 65 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
Shreveport, Louisiana
Source: ClinicalTrials.gov public record
Updated Jul 1, 2024 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 1 Interventional

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

NCT06627413
View directory record Official record
Conditions
Schizophrenia or Schizoaffective
Interventions
Lumateperone Capsule, Lumateperone LAI
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
4
States / cities
Los Alamitos, California • Atlanta, Georgia • Marlton, New Jersey
Source: ClinicalTrials.gov public record
Updated Jul 31, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 3 Interventional

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

NCT06706674
View directory record Official record
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
Lumateperone high dose, Lumateperone low dose, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
5 Years to 17 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
40
States / cities
Little Rock, Arkansas • Sacramento, California • Sherman Oaks, California + 31 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

NCT06462586
View directory record Official record
Conditions
Bipolar Disorder, Manic
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
354 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
23
States / cities
Rogers, Arkansas • Bellflower, California • Culver City, California + 18 more
Source: ClinicalTrials.gov public record
Updated Jul 24, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02469155
View directory record Official record
Conditions
Schizophrenia
Interventions
ITI-007, Risperidone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
696 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
11
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Culver City, California + 8 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2025 · Synced Oct 21, 2026, 7:42 AM EDT
Recruiting Phase 4 Interventional

Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia

NCT06174116
View directory record Official record
Conditions
Schizophrenia, Schizo Affective Disorder
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
18 Years to 65 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 22, 2026 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers

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

NCT02078310
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
ITI-007, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
65 Years and older
Enrollment
35 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Nov 17, 2017 · Synced Oct 21, 2026, 7:42 AM EDT
Completed Phase 2 Interventional

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

NCT02288845
View directory record Official record
Conditions
Schizophrenia
Interventions
ITI-007
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 10, 2017 · Synced Oct 21, 2026, 7:42 AM EDT