Lumateperone

DRUG15 trials

Sponsors

Intra-Cellular Therapies, Inc., University of New Mexico, University of Massachusetts, Worcester, Eric Lenze, Watim Medical & Dental College

Conditions

Autism Spectrum DisorderBipolar 1 DepressionBipolar DepressionBipolar DisorderBipolar Disorder, ManicDepression / Major Depressive DisorderDepressive Disorder, MajorLate Life Depression (LLD)

Phase 3

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

CompletedNCT03249376

Intra-Cellular Therapies, Inc.Bipolar Depression

Start: 2017-11-27End: 2019-03-01Updated: 2022-06-03

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

CompletedNCT04285515

Intra-Cellular Therapies, Inc.Bipolar Depression, Major Depressive Disorder

Start: 2020-02-27End: 2022-11-30Updated: 2025-03-19

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

CompletedNCT04985942

Intra-Cellular Therapies, Inc.Major Depressive Disorder

Start: 2021-07-30End: 2024-02-27Updated: 2025-05-02

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

CompletedNCT05061719

Intra-Cellular Therapies, Inc.Major Depressive Disorder

Start: 2021-10-08End: 2024-10-23Updated: 2025-11-03

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

CompletedNCT05061706

Intra-Cellular Therapies, Inc.Major Depressive Disorder

Start: 2021-09-30End: 2024-04-12Updated: 2025-05-09

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

RecruitingNCT05850689

Intra-Cellular Therapies, Inc.Major Depressive Disorder

Start: 2023-05-02End: 2027-04-05Target: 470Updated: 2026-08-28

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

RecruitingNCT06229210

Intra-Cellular Therapies, Inc.Autism Spectrum Disorder, Bipolar Disorder, Schizophrenia

Start: 2024-01-25End: 2032-04-28Target: 300Updated: 2026-08-28

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

RecruitingNCT06372964

Intra-Cellular Therapies, Inc.Bipolar Depression

Start: 2024-05-14End: 2031-10-31Target: 384Updated: 2026-08-28

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

CompletedNCT06462612

Intra-Cellular Therapies, Inc.Bipolar Disorder, Manic

Start: 2024-07-17End: 2026-05-20Updated: 2026-07-24

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

CompletedNCT06462586

Intra-Cellular Therapies, Inc.Bipolar Disorder, Manic

Start: 2024-06-19End: 2026-03-05Updated: 2026-07-24

Lumateperone for Late-Life Depression

RecruitingNCT07623135

Eric LenzeDepression / Major Depressive Disorder, Late Life Depression (LLD), Treatment Resistant Depression (TRD)

Start: 2026-09-01End: 2028-06-01Target: 100Updated: 2026-09-16

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

Not yet recruitingNCT07747389

Intra-Cellular Therapies, Inc.Depressive Disorder, Major

Start: 2026-10-20End: 2029-09-20Target: 585Updated: 2026-08-31

Phase 4

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

WithdrawnNCT05890768

University of New MexicoPsychosis

Start: 2023-05-11End: 2024-02-28Updated: 2025-03-05

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

RecruitingNCT06174116

University of Massachusetts, WorcesterSchizo Affective Disorder, Schizophrenia

Start: 2024-04-02End: 2027-03-01Target: 50Updated: 2026-05-22

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 recruitingNCT07676669

Watim Medical & Dental CollegeBipolar 1 Depression

Start: 2026-12-01End: 2027-08-01Target: 140Updated: 2026-09-09

Related Papers

Safety and Tolerability of Adjunctive Lumateperone for the Treatment of Major Depressive Disorder: A Pooled Analysis of Two Randomized Placebo-Controlled Trials.

2026-07-15

Long-term adjunctive lumateperone 42 mg treatment in major depressive disorder: Results from a 6-month open-label extension study

European Neuropsychopharmacology2026-03-24

Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder

The Journal of Clinical Psychiatry2025-08-253 citations

610. LONG-TERM ADJUNCTIVE LUMATEPERONE TREATMENT IN MAJOR DEPRESSIVE DISORDER: RESULTS FROM A SIX-MONTH OPEN-LABEL EXTENSION STUDY

The International Journal of Neuropsychopharmacology2025-08-01

612. EFFICACY OF LUMATEPERONE 42 MG IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER: A POOLED ANALYSIS OF PHASE 3 RANDOMIZED CONTROLLED TRIALS

The International Journal of Neuropsychopharmacology2025-08-01

Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features

Journal of Clinical Psychopharmacology2025-02-1311 citations

LUMATEPERONE TREATMENT FOR MAJOR DEPRESSIVE EPISODES WITH MIXED FEATURES IN MAJOR DEPRESSIVE DISORDER AND BIPOLAR I OR BIPOLAR II DISORDER

The International Journal of Neuropsychopharmacology2025-02-01

LUMATEPERONE IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER AND BIPOLAR DISORDER WITH ANXIOUS DISTRESS AND MIXED FEATURES

The International Journal of Neuropsychopharmacology2025-02-01

The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features

The Journal of Clinical Psychiatry2023-04-1916 citations

Long-Term Lumateperone Treatment in Bipolar Disorder: Six-Month Open-Label Extension Study

CNS Spectrums2023-04-014 citations

Metabolic Syndrome in Bipolar Depression with Lumateperone (ITI-007): A Post Hoc Analysis of 2 Randomized, Placebo-Controlled Trials

CNS Spectrums2023-04-013 citations

Effect of Lumateperone (ITI-007) on Quality of Life and Functional Disability in the Treatment of Bipolar Depression

CNS Spectrums2023-04-01

Lumateperone (ITI−007) in the Treatment of Bipolar Depression: Results from a Randomized Clinical Trial

CNS Spectrums2021-04-019 citations