Adults 18 to 75, any sex, with Bipolar Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total ScorePrimary· Day 43
The Montgomery-Åsberg Depression Rating Scale 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.
Group
Value
95% CI
Lumateperone 42mg
-18.1
± 0.71
Placebo
-12.4
± 0.70
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total ScorePrimary· Day 43
The Montgomery-Åsberg Depression Rating Scale 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.
Group
Value
95% CI
Lumateperone 42mg
-17.7
± 1.00
Placebo
-12.0
± 0.96
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total ScorePrimary· Day 43
The Montgomery-Åsberg Depression Rating Scale 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.
Group
Value
95% CI
Lumateperone 42mg
-18.2
± 0.95
Placebo
-12.2
± 0.96
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total ScorePrimary· Day 43
The Montgomery-Åsberg Depression Rating Scale 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.
Group
Value
95% CI
Lumateperone 42mg
-17.7
± 0.64
Placebo
-12.1
± 0.63
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)Secondary· Day 43
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Group
Value
95% CI
Lumateperone 42mg
-1.8
± 0.08
Placebo
-1.2
± 0.08
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)Secondary· Day 43
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Group
Value
95% CI
Lumateperone 42mg
-1.8
± 0.11
Placebo
-1.2
± 0.11
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)Secondary· Day 43
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Group
Value
95% CI
Lumateperone 42mg
-1.7
± 0.11
Placebo
-1.1
± 0.11
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)Secondary· Day 43
The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Group
Value
95% CI
Lumateperone 42mg
-1.7
± 0.07
Placebo
-1.1
± 0.07
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05890768 — Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine
· Phase 4
· withdrawn
NCT05061719 — An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
· Phase 3
· completed
NCT05061706 — Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
· Phase 3
· completed
NCT04985942 — Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
· Phase 3
· completed
NCT03249376 — Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
· Phase 3
· completed
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intra-Cellular Therapies, Inc.
Last refreshed: 19 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04285515.