How many clinical trials are studying Lumateperone?

5 recruiting trials in our tracked data involve Lumateperone.

What conditions is Lumateperone being studied for?

In our tracked recruiting trials, Lumateperone is being studied in trials for Depression, Bipolar Disorder, Schizophrenia.

Lumateperone: clinical trials recruiting now

Q: Is Lumateperone FDA-approved?

Yes. According to the FDA drug label available through openFDA, Lumateperone is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Lumateperone appears in the FDA drug-label database. Marketed as CAPLYTA.
Drug class: Atypical Antipsychotic (FDA established pharmacologic class)
Boxed warning: The FDA label for Lumateperone carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. ( 1 ) Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. ( 1 )

FDA label via openFDA

Phase breakdown

Phase 3 4 Phase 4 1

Conditions being studied

Condition	Trials
Depression · Lumateperone for Depression	3
Bipolar Disorder	2
Schizophrenia	2
Autism Spectrum Disorder	1
Bipolar Depression	1
Depression / Major Depressive Disorder	1
Late Life Depression (LLD)	1
Major Depressive Disorder	1
Schizo Affective Disorder	1
Treatment Resistant Depression (TRD)	1

Recruiting trials involving Lumateperone

Lumateperone for Late-Life Depression
NCT07623135 · Phase: Phase 3 · Ages: 60 Years and older · Sex: All (male and female) · 2 locations
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
NCT06174116 · Phase: Phase 4 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
NCT06372964 · Phase: Phase 3 · Ages: 10 Years to 17 Years · Sex: All (male and female) · 68 locations
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
NCT06229210 · Phase: Phase 3 · Ages: 5 Years to 17 Years · Sex: All (male and female) · 64 locations
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05850689 · Phase: Phase 3 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 69 locations

Common questions

Is Lumateperone FDA-approved?

Yes, marketed as CAPLYTA. Its FDA label carries a boxed warning.

How many recruiting trials involve Lumateperone?

5 recruiting trials across 10 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.