19 completed, 11 recruiting, 3 not yet recruiting, 2 terminated. 21 Phase 3, 6 Phase 2, 6 Phase 4, 4 Phase 1.
Follow lumateperone: new trials by email Literature Review of lumateperone trials Research Report on lumateperone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| This Study Aims to Compare the Efficacy and Safety of Lumateperone and Cariprazine in Patients With Bipolar I Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression Bipolar Severity Scale (CGI-BP-S) and Recording Treatment Emergent Adverse Effects Lumateperone, Cariprazine - Bipolar 1 Depression | Phase 4 | Not yet recruiting | Watim Medical & Dental College | 140 | 2026-12-01 | 2026-10-07 |
| A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder Lumateperone, Placebo - Depressive Disorder, Major | Phase 3 | Not yet recruiting | Intra-Cellular Therapies, Inc. | 585 | 2026-11-11 | 2026-11-03 |
| Caplyta Versus Placebo for Adults With Social Anxiety Disorder Lumateperone 42 mg, Placebo - Social Anxiety Disorder (SAD) | Phase 4 | Recruiting | Jason Careri | 40 | 2026-09-10 | 2026-09-15 |
| The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression Lumateperone 42 mg - Bipolar Depression Depressed Phase, Obesity & Overweight | Phase 4 | Recruiting | Massachusetts General Hospital | 25 | 2026-09-09 | 2026-09-11 |
| Lumateperone for Late-Life Depression Lumateperone, Placebo - Treatment Resistant Depression (TRD), Late Life Depression (LLD) | Phase 3 | Recruiting | Eric Lenze | 100 | 2026-09-01 | 2026-09-16 |
| Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder Lumateperone (ITI-007), Placebo Tablet or Capsule - Stuttering, Adult | Phase 2 | Recruiting | CSTrials Inc. | 24 | 2026-04-18 | 2026-07-29 |
| Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse Lumateperone 42 mg, Placebo - Major Depressive Diorder, Early Life Trauma | Phase 4 | Not yet recruiting | University of Texas at Austin | 50 | 2026-02-01 | 2026-01-27 |
| Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients Lumateperone high dose, Lumateperone low dose, Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 160 | 2024-12-06 | 2026-11-03 |
| Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients Lumateperone high dose, Lumateperone low dose, Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 160 | 2024-11-22 | 2026-11-03 |
| Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder Lumateperone Capsule, Lumateperone LAI - Schizophrenia or Schizoaffective | Phase 1 | Completed | Intra-Cellular Therapies, Inc. | 52 | 2024-08-23 | 2026-07-31 |
| Study of Lumateperone in the Treatment of Patients With Bipolar Mania Lumateperone, Placebo - Bipolar Disorder, Manic | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 351 | 2024-07-17 | 2026-07-24 |
| Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania Lumateperone, Placebo - Bipolar Disorder, Manic | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 354 | 2024-06-19 | 2026-07-24 |
| Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms. Lumateperone 42 mg, Risperidone 2 mg - Apathy, Schizophrenia | Phase 3 | Recruiting | Louisiana State University Health Sciences Center Shreveport | 80 | 2024-06-01 | 2024-07-01 |
| Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients Lumateperone, Placebo - Bipolar Depression | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 384 | 2024-05-14 | 2026-11-03 |
| Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder Lumateperone 10.5 mg capsule, Lumateperone 21 mg capsule, Lumateperone 5 mg ODT - Autism Spectrum Disorder | Phase 1 | Completed | Intra-Cellular Therapies, Inc. | 33 | 2024-05-10 | 2026-07-24 |
| Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia Lumateperone, Placebo - Schizophrenia, Schizo Affective Disorder | Phase 4 | Recruiting | University of Massachusetts, Worcester | 50 | 2024-04-02 | 2026-05-22 |
| Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder Lumateperone - Schizophrenia, Bipolar Disorder | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 300 | 2024-01-25 | 2026-11-03 |
| Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine Lumateperone, Risperidone - Psychosis | Phase 4 | Withdrawn | University of New Mexico | 2023-05-11 | 2025-03-05 | |
| Caplyta in Borderline Personality Disorder Caplyta, Placebo - Borderline Personality Disorder | Phase 2 | Completed | University of Chicago | 60 | 2023-05-10 | 2026-07-29 |
| Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Lumateperone, Placebo - Major Depressive Disorder | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 470 | 2023-05-02 | 2026-11-03 |
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Schizophrenia (11) · Bipolar Disorder (9) · Depressive Disorder, Major (7) · Psychotic Disorders (3) · Autism Spectrum Disorder (2) · Depression (2) · Aberrant Motor Behavior in Dementia (1) · Alzheimer Disease (1) · Borderline Personality Disorder (1) · Dementia (1) · Depressive Disorder, Treatment-Resistant (1) · Lethargy (1) · Mental Disorders (1) · Obesity (1) · Overweight (1)
Intra-Cellular Therapies, Inc. (25) · CSTrials Inc. (1) · Eric Lenze (1) · Jason Careri (1) · Louisiana State University Health Sciences Center Shreveport (1) · Massachusetts General Hospital (1) · New York State Psychiatric Institute (1) · University of Chicago (1) · University of Massachusetts, Worcester (1) · University of New Mexico (1) · University of Texas at Austin (1) · Watim Medical & Dental College (1)
United States (34) · Bulgaria (10) · Serbia (10) · India (5) · Colombia (3) · Poland (3) · Russia (3) · Ukraine (3) · Czechia (2) · Finland (2) · Germany (2) · Hungary (2) · Slovakia (2) · Sweden (2) · Argentina (1)
Intra-Cellular Therapies, Inc. Clinical Trial (10) · Susan Kozauer, MD (4) · Kimberly Vanover, Ph.D. (3) · Dean F. Wong, M.D., Ph.D. (1) · Eric J Lenze, MD (1) · Gerald A Maguire, MD (1) · Jason Careri, MD (1) · Jeffrey A Lieberman, MD (1) · Jon E Grant, MD, JD, MPH (1) · Juan Bustillo, MD (1) · Kimberly E Vanover, PhD (1) · Michael E Henry, MD (1) · Shawn McNeil, MD (1) · Susan Kozauer, M.D. (1)
PMID 36883881, PMID 41017591, PMID 42455478, PMID 26444072, PMID 28738099, PMID 31369655, PMID 31913424, PMID 33642973, PMID 34551584, PMID 36779257, PMID 37103915, PMID 39946099, PMID 40875502, PMID 42690086, PMID 42752587
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