Lumateperone

Generic Name: Lumateperone

Brand Names: Caplyta

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈FN_₃O

CAS Number: 313368-91-1

Unique Ingredient Identifier: 70BSQ12069

Background: Schizophrenia is a complex mental illness and impacts approximately 1% of the population. Although there are several antipsychotics including aripiprazole, paliperidone and clozapine available for clinical use, they are generally accompanied by significant metabolic and/or neurological adverse effects.
...

Indication: Lumateperone is approved for the treatment of schizophrenia in adults. It is also approved for the treatment of depressive episodes associated with bipolar disorder (i.e. bipolar depression) in adults, as monotherapy and/or adjunctive therapy with lithium or valproate.

Associated Conditions: Depressive Episodes, Schizophrenia

Associated Therapies: -

Clinical Trials

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

Phase 3

Recruiting

Conditions: Bipolar Disorder, Manic

Interventions: Drug: Placebo
Drug: Lumateperone

First Posted Date: 2024-06-17

Last Posted Date: 2024-07-29

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 350

Registration Number: NCT06462612

Locations: 🇺🇸
Clinical Site, Richardson, Texas, United States

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

Phase 3

Recruiting

Conditions: Bipolar Disorder, Manic

Interventions: Drug: Lumateperone
Drug: Placebo

First Posted Date: 2024-06-17

Last Posted Date: 2024-07-29

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 350

Registration Number: NCT06462586

Locations: 🇺🇸
Clinical Site, DeSoto, Texas, United States

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

Phase 3

Recruiting

Conditions: Bipolar Depression

Interventions: Drug: Placebo
Drug: Lumateperone

First Posted Date: 2024-04-18

Last Posted Date: 2024-07-29

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 384

Registration Number: NCT06372964

Locations: 🇺🇸
Clinical Site, Bellevue, Washington, United States

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

Phase 3

Recruiting

Conditions: Schizophrenia
Bipolar Disorder

Interventions: Drug: Lumateperone

First Posted Date: 2024-01-29

Last Posted Date: 2024-01-30

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 500

Registration Number: NCT06229210

Locations: 🇺🇸
Clinical Site, Oklahoma City, Oklahoma, United States

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

Phase 4

Recruiting

Conditions: Schizophrenia
Schizo Affective Disorder

Interventions: Drug: Placebo
Drug: Lumateperone

First Posted Date: 2023-12-18

Last Posted Date: 2024-05-03

Lead Sponsor: University of Massachusetts, Worcester

Target Recruit Count: 50

Registration Number: NCT06174116

Locations: 🇺🇸
UMass Chan Medical School, Worcester, Massachusetts, United States

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Phase 4

Terminated

Conditions: Psychosis

Interventions: Drug: Lumateperone
Drug: Risperidone

First Posted Date: 2023-06-06

Last Posted Date: 2024-06-12

Lead Sponsor: University of New Mexico

Target Recruit Count: 5

Registration Number: NCT05890768

Locations: 🇺🇸
University of New Mexico, Albuquerque, New Mexico, United States

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

Phase 3

Recruiting

Conditions: Major Depressive Disorder

Interventions: Drug: Lumateperone
Drug: Placebo

First Posted Date: 2023-05-09

Last Posted Date: 2024-11-01

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 470

Registration Number: NCT05850689

Locations: 🇧🇬
Clincal Site, Stara Zagora, Bulgaria
🇪🇸
Clinical Site, Zamora, Spain

Caplyta in Borderline Personality Disorder

Phase 2

Recruiting

Conditions: Borderline Personality Disorder

Interventions: Drug: Placebo
Drug: Caplyta

First Posted Date: 2022-05-02

Last Posted Date: 2024-07-25

Lead Sponsor: University of Chicago

Target Recruit Count: 60

Registration Number: NCT05356013

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

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

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Lumateperone

First Posted Date: 2021-09-29

Last Posted Date: 2024-12-19

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 812

Registration Number: NCT05061719

Locations: 🇵🇱
Clinical SIte, Toruń, Poland
🇨🇿
Clinical site, Brno, Czechia
🇸🇪
Clinical Site, Stockholm, Sweden

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

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Lumateperone

First Posted Date: 2021-09-29

Last Posted Date: 2024-06-27

Lead Sponsor: Intra-Cellular Therapies, Inc.

Target Recruit Count: 480

Registration Number: NCT05061706

Locations: 🇩🇪
Clinical site, Freiburg im Breisgau, Germany
🇸🇪
Clinical Site, Stockholm, Sweden

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