Trial Outcomes & Findings for An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder (NCT NCT05061719)

Last Updated: 2025-11-03

Results Overview

An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

812 participants

Primary outcome timeframe

26 weeks

Results posted on

2025-11-03

Participant Flow

812 patients were enrolled; 809 patients received at least one dose of study drug and included in the Safety Population.

Participant milestones

Participant milestones
Measure	Lumateperone 42 mg Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Overall Study STARTED	809
Overall Study COMPLETED	684
Overall Study NOT COMPLETED	125

Reasons for withdrawal

Reasons for withdrawal
Measure	Lumateperone 42 mg Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Overall Study Adverse Event	60
Overall Study Death	1
Overall Study Lack of Efficacy	7
Overall Study Lost to Follow-up	5
Overall Study Pregnancy	1
Overall Study Protocol Violation	8
Overall Study Withdrawal by Subject	41
Overall Study Site Closure	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumateperone 42 mg n=809 Participants Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Age, Continuous	46.2 years STANDARD_DEVIATION 12.22 • n=3 Participants
Sex: Female, Male Female	549 Participants n=3 Participants
Sex: Female, Male Male	260 Participants n=3 Participants
Race/Ethnicity, Customized White	703 Participants n=3 Participants
Race/Ethnicity, Customized Black or African American	37 Participants n=3 Participants
Race/Ethnicity, Customized Asian	61 Participants n=3 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=3 Participants
Race/Ethnicity, Customized Multiple	4 Participants n=3 Participants
Race/Ethnicity, Customized Other	2 Participants n=3 Participants
Region of Enrollment Sweden	2 participants n=3 Participants
Region of Enrollment Hungary	15 participants n=3 Participants
Region of Enrollment United States	225 participants n=3 Participants
Region of Enrollment Czechia	95 participants n=3 Participants
Region of Enrollment Poland	147 participants n=3 Participants
Region of Enrollment Slovakia	32 participants n=3 Participants
Region of Enrollment Bulgaria	159 participants n=3 Participants
Region of Enrollment Germany	25 participants n=3 Participants
Region of Enrollment India	53 participants n=3 Participants
Region of Enrollment Argentina	56 participants n=3 Participants

PRIMARY outcome

Timeframe: 26 weeks

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg n=809 Participants Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events	548 Participants

SECONDARY outcome

Timeframe: 32 weeks

The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg n=809 Participants Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale	-21.7 score on a scale Standard Deviation 8.39

SECONDARY outcome

Timeframe: 32 weeks

The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).

Outcome measures

Outcome measures
Measure	Lumateperone 42 mg n=809 Participants Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity	-2.5 score on a scale Standard Deviation 1.19

Adverse Events

Lumateperone 42 mg

Serious events: 8 serious events

Other events: 322 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lumateperone 42 mg n=809 participants at risk Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Injury, poisoning and procedural complications Alcohol Poisoning	0.12% 1/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Injury, poisoning and procedural complications Contusion	0.12% 1/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.12% 1/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.25% 2/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Hepatobiliary disorders Biliary colic	0.12% 1/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Infections and infestations Helicobacter gastritis	0.12% 1/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.12% 1/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.

Other adverse events

Other adverse events
Measure	Lumateperone 42 mg n=809 participants at risk Lumateperone: Lumateperone 42 mg capsules administered orally, once daily
Nervous system disorders Headache	16.6% 134/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Nervous system disorders Dizziness	10.6% 86/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Gastrointestinal disorders Dry mouth	8.0% 65/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Gastrointestinal disorders Nausea	7.7% 62/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Nervous system disorders Somnolence	7.2% 58/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Gastrointestinal disorders Diarrhoea	6.2% 50/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
Infections and infestations Nasopharyngitis	5.2% 42/809 • From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.

Additional Information

ITI Clinical Trials

Intra-Cellular Therapies, Inc.

Phone: 646 440-9333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place