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ClinicalTrials.gov public records Last synced Sep 19, 2026, 11:44 AM EDT

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Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
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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
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
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
Conditions
Schizophrenia
Interventions
Lumateperone 42 mg, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
228 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
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
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
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
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
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
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
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
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
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
ITI-007, Placebo
Drug
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
11
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Escondido, California + 8 more
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
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
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
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
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
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
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
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