Adults 18 to 65, any sex, with 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.
Montgomery-Asberg Depression Rating ScalePrimary· Day 43
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 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.
Group
Value
95% CI
Lumateperone 42 mg
-14.7
± 0.56
Placebo
-10.2
± 0.54
Clinical Global Impression Scale-SeveritySecondary· Day 43
Change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S). The CGI-S 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 42 mg
-1.5
± 0.07
Placebo
-1.0
± 0.07
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing ICF until end of study procedures (~9 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 multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
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· withdrawn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
NCT04985942 — Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
· Phase 3
· completed
NCT04285515 — Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
· Phase 3
· completed
NCT03249376 — Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
· Phase 3
· completed
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Currently open trials in the same condition.
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NCT06749392 — An Individual-specific Synchrony Signature
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NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness
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NCT07242105 — Optimizing Brain Excitability in Depression
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Other Intra-Cellular Therapies, Inc. trials
Trials by the same sponsor.
NCT06786286 — A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
· Phase 1
· completed
NCT06627413 — Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizoph
· Phase 1
· completed
NCT06557902 — Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
· Phase 1
· recruiting
NCT05732194 — Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteer
· Phase 1
· completed
NCT05470101 — A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
· Phase 1
· completed
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: 9 May 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/NCT05061706.