GLP-1 Market
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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Lumateperone

Company
Massachusetts General Hospital
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
10 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

10 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Sep 12, 2026

Find a Clinical Trial Near Me

See recruiting studies for Lumateperone and check eligibility with the study team.

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Treatment type

"Added to GLP-1" means the investigational treatment is being studied on top of an existing GLP-1-based therapy.

Your ZIP code is only used to calculate distance to trial sites — it isn't stored.

Trial details
  • Recruiting NCT NCT05850689

    Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 470 participants Est. completion 2027-04-05 69 sites Stand-alone
    Other conditions: Major Depressive Disorder
    View official trial listing →
  • Recruiting NCT NCT06174116

    Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia

    Not yet reported University of Massachusetts, Worcester 50 participants Est. completion 2027-03 1 site Stand-alone
    Other conditions: Schizophrenia, Schizo Affective Disorder
    View official trial listing →
  • Recruiting NCT NCT06229210

    Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 300 participants Est. completion 2032-04-28 64 sites Stand-alone
    Other conditions: Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
    View official trial listing →
  • Recruiting NCT NCT06372964

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

    Not yet reported Intra-Cellular Therapies, Inc. 384 participants Est. completion 2031-10-31 68 sites Stand-alone
    Other conditions: Bipolar Depression
    View official trial listing →
  • Recruiting NCT NCT06482554

    Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

    Not yet reported Louisiana State University Health Sciences Center Shreveport 80 participants Est. completion 2026-12 1 site
    Other conditions: Apathy, Schizophrenia, Schizophrenia; Psychosis
    View official trial listing →
  • Recruiting NCT NCT06690398

    Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

    Not yet reported Intra-Cellular Therapies, Inc. 160 participants Est. completion 2027-07-19 35 sites Stand-alone
    Other conditions: Irritability Associated With Autism Spectrum Disorder
    View official trial listing →
  • Recruiting NCT NCT06706674

    Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

    Not yet reported Intra-Cellular Therapies, Inc. 160 participants Est. completion 2027-06-21 40 sites Stand-alone
    Other conditions: Irritability Associated With Autism Spectrum Disorder
    View official trial listing →
  • Recruiting NCT NCT07623135

    Lumateperone for Late-Life Depression

    Not yet reported Eric Lenze 100 participants Est. completion 2028-06 2 sites Stand-alone
    Other conditions: Treatment Resistant Depression (TRD), Late Life Depression (LLD), Depression / Major Depressive Disorder
    View official trial listing →
  • Recruiting NCT NCT07699445

    The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression

    Not yet reported Massachusetts General Hospital 25 participants Est. completion 2028-07-31 1 site Stand-alone
    Other conditions: Bipolar Depression Depressed Phase, Obesity & Overweight
    View official trial listing →
  • Recruiting NCT NCT07734103

    Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder

    Not yet reported CSTrials Inc. 24 participants Est. completion 2027-10-31 1 site Stand-alone
    Other conditions: Stuttering, Adult
    View official trial listing →
  • Completed NCT NCT01499563

    Study of a Novel Antipsychotic ITI-007 in Schizophrenia

    Not yet reported Intra-Cellular Therapies, Inc. 335 participants Est. completion 2013-11 8 sites Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT02078310

    Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

    Not yet reported, Not yet reported Intra-Cellular Therapies, Inc. 35 participants Est. completion 2014-11 1 site
    Other conditions: Alzheimer's Disease
    View official trial listing →
  • Completed NCT NCT02282761

    A Trial to Assess the Antipsychotic Efficacy of ITI-007

    Not yet reported Intra-Cellular Therapies, Inc. 450 participants Est. completion 2015-09 11 sites Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT02288845

    Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

    Not yet reported Intra-Cellular Therapies, Inc. 14 participants Est. completion 2015-09 1 site
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT02469155

    A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

    Not yet reported Intra-Cellular Therapies, Inc. 696 participants Est. completion 2016-08 11 sites Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT02600494

    Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

    Not yet reported Intra-Cellular Therapies, Inc. 554 participants Est. completion 2019-07-24 55 sites Stand-alone
    Other conditions: Bipolar Depression
    View official trial listing →
  • Completed NCT NCT02600507

    Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

    Not yet reported Intra-Cellular Therapies, Inc. 529 participants Est. completion 2020-07-02 71 sites Stand-alone
    Other conditions: Bipolar Depression
    View official trial listing →
  • Terminated NCT NCT02817906

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

    Not yet reported Intra-Cellular Therapies, Inc. 177 participants Est. completion 2019-01-30 26 sites
    Other conditions: Agitation in Dementia, Including Alzheimer's Disease
    View official trial listing →
  • Completed NCT NCT03249376

    Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

    Not yet reported Intra-Cellular Therapies, Inc. 381 participants Est. completion 2019-03-01 47 sites Stand-alone
    Other conditions: Bipolar Depression
    View official trial listing →
  • Terminated NCT NCT03817528

    ITI-007 (Lumateperone Tosylate) for Schizophrenia

    Not yet reported New York State Psychiatric Institute 4 participants Est. completion 2020-09-23 1 site Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT04285515

    Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 488 participants Est. completion 2022-11-30 42 sites Stand-alone
    Other conditions: Bipolar Depression, Major Depressive Disorder
    View official trial listing →
  • Completed NCT NCT04709224

    Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia

    Not yet reported Intra-Cellular Therapies, Inc. 37 participants Est. completion 2022-05-23 2 sites Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT04779177

    Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 26 participants Est. completion 2022-07-30 3 sites Stand-alone
    Other conditions: Schizophrenia, Pediatric
    View official trial listing →
  • Completed NCT NCT04959032

    Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

    Not yet reported Intra-Cellular Therapies, Inc. 228 participants Est. completion 2024-08-07 43 sites Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT04985942

    Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 485 participants Est. completion 2024-02-27 54 sites Stand-alone
    Other conditions: Major Depressive Disorder
    View official trial listing →
  • Completed NCT NCT05061706

    Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 480 participants Est. completion 2024-04-12 50 sites Stand-alone
    Other conditions: Major Depressive Disorder
    View official trial listing →
  • Completed NCT NCT05061719

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

    Not yet reported Intra-Cellular Therapies, Inc. 812 participants Est. completion 2024-10-23 109 sites Stand-alone
    Other conditions: Major Depressive Disorder
    View official trial listing →
  • Completed NCT NCT05356013

    Caplyta in Borderline Personality Disorder

    Not yet reported University of Chicago 60 participants Est. completion 2025-12-31 1 site Stand-alone
    Other conditions: Borderline Personality Disorder
    View official trial listing →
  • Withdrawn NCT NCT05890768

    Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

    Not yet reported University of New Mexico Est. completion 2024-02-28 1 site Stand-alone
    Other conditions: Psychosis
    View official trial listing →
  • Completed NCT NCT06462586

    Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

    Not yet reported Intra-Cellular Therapies, Inc. 354 participants Est. completion 2026-03-05 42 sites Stand-alone
    Other conditions: Bipolar Disorder, Manic
    View official trial listing →
  • Completed NCT NCT06462612

    Study of Lumateperone in the Treatment of Patients With Bipolar Mania

    Not yet reported Intra-Cellular Therapies, Inc. 351 participants Est. completion 2026-05-20 35 sites Stand-alone
    Other conditions: Bipolar Disorder, Manic
    View official trial listing →
  • Completed NCT NCT06557902

    Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 33 participants Est. completion 2025-11-26 7 sites Stand-alone
    Other conditions: Autism Spectrum Disorder
    View official trial listing →
  • Completed NCT NCT06627413

    Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 52 participants Est. completion 2025-11-20 4 sites Stand-alone
    Other conditions: Schizophrenia or Schizoaffective
    View official trial listing →
  • Not yet recruiting NCT NCT07369115

    Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse

    Not yet reported University of Texas at Austin 50 participants Est. completion 2030-01 1 site
    Other conditions: Major Depressive Diorder, Early Life Trauma
    View official trial listing →
  • Not yet recruiting NCT NCT07676669

    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

    Not yet reported Watim Medical & Dental College 140 participants Est. completion 2027-08 Stand-alone
    Other conditions: Bipolar 1 Depression
    View official trial listing →
  • Not yet recruiting NCT NCT07747389

    A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder

    Not yet reported Intra-Cellular Therapies, Inc. 585 participants Est. completion 2029-09-20 Stand-alone
    Other conditions: Depressive Disorder, Major
    View official trial listing →
  • Not yet recruiting NCT NCT07799493

    Caplyta Versus Placebo for Adults With Social Anxiety Disorder

    Not yet reported Jason Careri 40 participants Est. completion 2028-05-28 1 site Stand-alone
    Other conditions: Social Anxiety Disorder (SAD)
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: Lumateperone, CAPLYTA, Lumateperone 42 mg

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.