Lumateperone

Generic Name
Lumateperone
Brand Names
Caplyta
Drug Type
Small Molecule
Chemical Formula
C24H28FN3O
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
-

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

Phase 3
Recruiting
Conditions
Interventions
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
๐Ÿ‡บ๐Ÿ‡ธ

Clinical Site, Richardson, Texas, United States

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

Phase 3
Recruiting
Conditions
Interventions
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
๐Ÿ‡บ๐Ÿ‡ธ

Clinical Site, DeSoto, Texas, United States

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

Phase 3
Recruiting
Conditions
Interventions
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
๐Ÿ‡บ๐Ÿ‡ธ

Clinical Site, Bellevue, Washington, United States

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

Phase 3
Recruiting
Conditions
Interventions
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
๐Ÿ‡บ๐Ÿ‡ธ

Clinical Site, Oklahoma City, Oklahoma, United States

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

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
๐Ÿ‡บ๐Ÿ‡ธ

UMass Chan Medical School, Worcester, Massachusetts, United States

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Phase 4
Terminated
Conditions
Interventions
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
๐Ÿ‡บ๐Ÿ‡ธ

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
Interventions
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
๐Ÿ‡ง๐Ÿ‡ฌ

Clincal Site, Stara Zagora, Bulgaria

๐Ÿ‡ช๐Ÿ‡ธ

Clinical Site, Zamora, Spain

Caplyta in Borderline Personality Disorder

Phase 2
Recruiting
Conditions
Interventions
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
๐Ÿ‡บ๐Ÿ‡ธ

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
Interventions
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
๐Ÿ‡ต๐Ÿ‡ฑ

Clinical SIte, Toruล„, Poland

๐Ÿ‡จ๐Ÿ‡ฟ

Clinical site, Brno, Czechia

๐Ÿ‡ธ๐Ÿ‡ช

Clinical Site, Stockholm, Sweden

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

Phase 3
Completed
Conditions
Interventions
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
๐Ÿ‡ฉ๐Ÿ‡ช

Clinical site, Freiburg im Breisgau, Germany

๐Ÿ‡ธ๐Ÿ‡ช

Clinical Site, Stockholm, Sweden

ยฉ Copyright 2024. All Rights Reserved by MedPath