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ClinicalTrials.gov public records Last synced Oct 4, 2026, 11:32 AM EDT

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Showing 1–24 of 43 matching trials from the live ClinicalTrials.gov search.
Filters: Sponsor: Intra-Cellular Therapies, Inc. Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

NCT06299410
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ITI-1284 10 mg, ITI-1284 20 mg
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
58 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2026
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 4, 2026, 11:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

NCT05470101
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ITI-333
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
2
States / cities
Creve Coeur, Missouri • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Sep 10, 2025 · Synced Oct 4, 2026, 11:32 AM EDT
Completed Phase 3 Interventional Results available

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT05061719
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Lumateperone
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
812 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
40
States / cities
Phoenix, Arizona • Bentonville, Arkansas • Little Rock, Arkansas + 35 more
Source: ClinicalTrials.gov public record
Updated Nov 3, 2025 · Synced Oct 4, 2026, 11:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

NCT04934124
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ITI-333, Placebo
Drug · Other
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Eatontown, New Jersey
Source: ClinicalTrials.gov public record
Updated Mar 14, 2023 · Synced Oct 4, 2026, 11:32 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 4, 2026, 11:32 AM EDT
Completed Phase 3 Interventional

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

NCT06462612
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
351 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
22
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Anaheim, California + 15 more
Source: ClinicalTrials.gov public record
Updated Jul 24, 2026 · Synced Oct 4, 2026, 11:32 AM EDT
Recruiting Phase 2 Interventional

Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

NCT06480383
View directory record Official record
Conditions
Generalized Anxiety Disorder
Interventions
ITI-1284 10 mg, ITI-1284 20 mg, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
Not listed
Enrollment
705 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
25
States / cities
Glendale, California • Imperial, California • Lemon Grove, California + 17 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 4, 2026, 11:32 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 4, 2026, 11:32 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 4, 2026, 11:32 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 4, 2026, 11:32 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 4, 2026, 11:32 AM EDT
Recruiting Phase 2 Interventional

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

NCT06540833
View directory record Official record
Conditions
Psychotic Disorders, Alzheimer Disease
Interventions
ITI-1284, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
55 Years and older
Enrollment
370 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
28
States / cities
Anaheim, California • Los Alamitos, California • Newport Beach, California + 20 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 4, 2026, 11:32 AM EDT
Recruiting Phase 2 Interventional

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

NCT06701903
View directory record Official record
Conditions
Generalized Anxiety Disorder
Interventions
ITI-1284 10 mg, ITI-1284 20 mg, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years and older
Enrollment
570 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
25
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Rogers, Arkansas + 21 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 4, 2026, 11:32 AM EDT
Recruiting Phase 3 Interventional

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

NCT06372964
View directory record Official record
Conditions
Bipolar Depression
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
384 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
56
States / cities
Dothan, Alabama • Little Rock, Arkansas • Anaheim, California + 38 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 4, 2026, 11:32 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 4, 2026, 11:32 AM EDT
Terminated Phase 3 Interventional Results available

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

NCT02817906
View directory record Official record
Conditions
Agitation in Dementia, Including Alzheimer's Disease
Interventions
ITI-007, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
55 Years and older
Enrollment
177 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
26
States / cities
Sun City, Arizona • Little Rock, Arkansas • Rogers, Arkansas + 23 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2021 · Synced Oct 4, 2026, 11:32 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 4, 2026, 11:32 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 4, 2026, 11:32 AM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia

NCT01900522
View directory record Official record
Conditions
Schizophrenia
Interventions
ITI-214 Dose A, ITI-214 Dose B, ITI-214 Dose C, ITI-214 Dose D (Elderly), Placebo, ITI-214 Dose E, ITI-214 Dose F, ITI-214 Dose G, ITI-214 Dose H
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
76 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
2
States / cities
Glendale, California • New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 19, 2015 · Synced Oct 4, 2026, 11:32 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 4, 2026, 11:32 AM EDT
Terminated Phase 2 Interventional Results available

ITI-007 (Lumateperone Tosylate) for Schizophrenia

NCT03817528
View directory record Official record
Conditions
Schizophrenia
Interventions
ITI-007
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years · Male only
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Nov 4, 2021 · Synced Oct 4, 2026, 11:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

NCT05732194
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ITI-333, Placebo
Drug · Other
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Oct 4, 2026, 11:32 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 4, 2026, 11:32 AM EDT
Recruiting Phase 2 Interventional

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

NCT06651567
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Dementia
Interventions
ITI-1284, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
55 Years and older
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
31
States / cities
Anaheim, California • Costa Mesa, California • Garden Grove, California + 18 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 4, 2026, 11:32 AM EDT