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
-

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2021-08-02
Last Posted Date
2024-04-24
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
485
Registration Number
NCT04985942
Locations
🇨🇿

Clinical site, Plzen, Czechia

🇸🇰

Clinical Site, Zlaté Moravce, Slovakia

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

First Posted Date
2020-02-26
Last Posted Date
2023-03-22
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
488
Registration Number
NCT04285515
Locations
🇺🇦

Clinical Site, Vinnytsia, Ukraine

🇺🇦

Clinical site, Odesa, Ukraine

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-08-15
Last Posted Date
2022-06-03
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
381
Registration Number
NCT03249376
Locations
🇺🇦

Clinical Site, Vinnytsia, Ukraine

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