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

StatusRecruiting
PhasePhase 3
Started2023-05-02
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 69 sites
2026-07-30
Study Status v8
Re-verified, no change to tracked fields
2026-07-22
Study Identification, Study Status, Contacts/Locations v7
Study sites68→69
2026-07-02
Study Status, Contacts/Locations v6
Primary completion date2026-09→2027-04-05
Completion date2026-10→2027-04-05
Study sites60→68
2025-06-30
Study Status, Contacts/Locations v5
Study sites37→60
Show 4 earlier versions
2024-10-30
Study Status, Eligibility, Contacts/Locations v4
Primary completion date2025-10→2026-09
Completion date2025-10→2026-10
Study sites18→37
Eligibility criteria+31 characters
[...] t of the current major depressive episode (MDE) is at least 812 weeks but not more than 18 months prior to Screening; Has a [...] reas of functioning. Currently having an inadequate response to ADT (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant T [...]
2024-01-09
Study Status, Contacts/Locations v3
Study sitesdetails revised at 13 of 18 sites
2024-01-03
Study Status v2
Start dateestimated 2023-05→confirmed 2023-05-02
2023-05-09
Study Status, Contacts/Locations v1
Study sitescontacts updated at 1 of 18 sites
2023-04-29
Original filing
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.
Trial Details
NCT Number NCT05850689
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Major Depressive Disorder
Enrollment 470 participants
Start Date 2023-05-02
Primary Completion 2027-04-05 (estimated)
Study Completion 2027-04-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-25