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ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:57 PM EDT

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Showing 1–24 of 35 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
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
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
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
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
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
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
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
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
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
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
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, 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
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
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
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
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
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
Social Anxiety Disorder (SAD)
Interventions
Lumateperone 42 mg, Placebo
Drug
Lead sponsor
Jason Careri
Network
Eligibility
18 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
New York, New York
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
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
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
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
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
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