Independent directory Public ClinicalTrials.gov records United States
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ClinicalTrials.gov public records Last synced Oct 8, 2026, 5:21 PM EDT

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Showing 25–43 of 43 matching trials from the live ClinicalTrials.gov search.
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
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
Conditions
Treatment Resistant Depression (TRD), Late Life Depression (LLD), Depression / Major Depressive Disorder
Interventions
Lumateperone, Placebo
Drug
Lead sponsor
Eric Lenze
Other
Eligibility
60 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
2
States / cities
Tucson, Arizona • St Louis, Missouri
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
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
Terminated Phase 2 Interventional Results available

ITI-007 (Lumateperone Tosylate) for Schizophrenia

NCT03817528
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
Conditions
Generalized Anxiety Disorder
Interventions
ITI-1284
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years and older
Enrollment
900 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
3
States / cities
Los Angeles, California • Miami, Florida • Brooklyn, New York
Conditions
Heart Failure, Systolic
Interventions
ITI-214, Placebo
Drug · Other
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
2
States / cities
Baltimore, Maryland • Durham, North Carolina
Conditions
Parkinson Disease
Interventions
Lenrispodun, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
40 Years and older
Enrollment
79 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
35
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Irvine, California + 31 more
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
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
Completed Phase 1 Interventional Accepts healthy volunteers

Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

NCT03489772
Conditions
Healthy Volunteers
Interventions
ITI-214, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
26 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Tulsa, Oklahoma
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
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
Completed Phase 2 Interventional Results available

Caplyta in Borderline Personality Disorder

NCT05356013
Conditions
Borderline Personality Disorder
Interventions
Caplyta, Placebo
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Chicago, Illinois
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
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
Conditions
Schizophrenia
Interventions
ITI-007, Placebo, Risperidone
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
335 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
8
States / cities
Little Rock, Arkansas • Garden Grove, California • Atlanta, Georgia + 5 more
Conditions
Schizophrenia
Interventions
Lumateperone 42 mg, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
592 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
21
States / cities
Little Rock, Arkansas • Bellflower, California • Cerritos, California + 18 more